TriangleNCT01185353 · CITED IN SOURCE DOCUMENTS
A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-06-16
The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12
Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response
Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24
Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128
Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24
Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128
Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24
Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128
Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response
ACR Percent Improvement (ACR-N)
Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)
Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC
Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score
Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)
Mean Change From Baseline to Weeks 76 and 128 in hsCRP
Mean Change From Baseline to Weeks 12 and 24 in Erythrocyte Sedimentation Rate (ESR)
Mean Change From Baseline to Weeks 76 and 128 in ESR
Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP
Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24
Percentage of Responders According to EULAR28 Baseline Through Weeks 76 and 128
Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24
Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128
Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness
Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Mean Change From Baseline to Week 12 in Brief Pain Inventory Modified Short Form (BPI-sf Modified) Worst-Pain-in-the Past-24-hours Item Score
Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Mean Change From Baseline Through Week 12 in the ENSEMBLE Minimum Data Set 1.0
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Must have active RA * Must regularly use methotrexate (MTX) for at least 12 weeks before your participation in this study * Must have American College of Rheumatology (ACR) functional class I, II, or III * Must have C-reactive protein (CRP) measurement \> 1.2 times upper limit of normal (ULN) or Erythrocyte Sedimentation Rate (ESR) \> ULN \[28 millimeters/hour (mm/hr)\] * Have laboratory values that in the opinion of the investigator do not pose an unacceptable risk to the participants if study drug would be administered * Must have venous access sufficient to allow blood sampling as per the protocol * Must be reliable and willing to be available for the duration of the study and are willing to follow study procedures * Must be able to read, understand, and give written informed consent approved by Lilly or its designee and the ethical review board (ERB) governing the site * Male participants: agree to use 2 forms of highly effective methods of birth control with female partners of childbearing potential during the study * If you are a woman and you could become pregnant during this study, you must talk to the study doctor about birth control. You are required to use 2 forms of highly effective methods of birth control to avoid getting pregnant during the study * If you are a post-menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months * If you are a woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test * For participants receiving corticosteroids, you must be on a dose not to exceed 10 mg of prednisone daily (or equivalent) and have been on the same dosing regimen for at least 6 weeks prior to randomization * Continue to meet inclusion criteria for Parts A and B as applicable * Part D only: have completed the 52 weeks (Week 24 to Week 76) of participation in Part C of the study without permanent study drug discontinuation and have not completed the Follow-Up Visit (approximately 28 days after the last dose of study drug) Exclusion Criteria: * Must not have received any parenteral corticosteroid administered by intra-articular, intramuscular (IM), or intravenous (IV) injection within 6 weeks prior to baseline * Must not be concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 4 weeks * Must not have received any prior biologic disease modifying anti-rheumatic drug (DMARD) therapy \[such as Tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6, T-cell or B-cell target therapies) * Must not have used DMARDs other than methotrexate (MTX), hydroxychloroquine, or sulfasalazine within the last 8 weeks * Must not have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body * Must not have previously been randomized, completed or withdrawn from this study or any other study investigating LY3009104 * Must not have received prior treatment with an oral JAK inhibitor * Must not have a current or recent (within the last 30 days) viral, bacterial, fungal, or parasitic infection * Must not have had a serious infection (for example, pneumonia, cellulitis, or bone or joint infections) or atypical mycobacterial infection within the last 6 months * Must not have had symptomatic herpes zoster or herpes simplex infection within the last 90 days or have a history of disseminated/complicated herpes zoster * Must not have evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies * Must not have evidence of hepatitis C virus (HCV) or active hepatitis B * Must not have evidence or suspicion of active or latent tuberculosis (TB) * Must not have another serious disorder or illness * Must not be exposed to a live vaccine within the last 12 weeks * Must not have donated more than 500 milliliters (mL) of blood within the last month * Must not have had surgery on a joint that is to be assessed in the study within the last 2 months, or will require such during the study * Must not be currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study * Presence of significant uncontrolled cerebro-cardiovascular \[for example (eg), myocardial infarction (MI), unstable angina (UA), unstable arterial hypertension, severe heart failure or cerebrovascular accident\], respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematologic or neuropsychiatric disorders, or abnormal laboratory values that in the opinion of the investigator pose an unacceptable risk to the participant if study drug would be administered
- healthy Volunteers
- false
- maximum Age
- 75 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Administered orally once daily for initial 12 weeks followed by randomization to either 4 mg LY3009104 once daily or 2 mg LY3009104 twice daily for an additional 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.
- intervention Names
- Drug: LY3009104
- Drug: Methotrexate
- label
- 1 mg LY3009104 once daily
- type
- EXPERIMENTAL
- description
- Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.
- intervention Names
- Drug: LY3009104
- Drug: Methotrexate
- label
- 2 mg LY3009104 once daily
- type
- EXPERIMENTAL
- description
- Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.
- intervention Names
- Drug: LY3009104
- Drug: Methotrexate
- label
- 4 mg LY3009104 once daily
- type
- EXPERIMENTAL
- description
- Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.
- intervention Names
- Drug: LY3009104
- Drug: Methotrexate
- label
- 8 mg LY3009104 once daily
- type
- EXPERIMENTAL
- description
- Placebo administered orally once daily for initial 12 weeks followed by randomization to either 4 mg LY3009104 once daily or 2 mg LY3009104 twice daily for an additional 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.
- intervention Names
- Drug: Placebo
- Drug: Methotrexate
- label
- Placebo once daily
- type
- PLACEBO_COMPARATOR
- description
- (Not utilized in Part A) After 12 weeks treatment with 1 mg LY3009104 once daily or Placebo once daily in Part A, administered orally twice daily for 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.
- intervention Names
- Drug: LY3009104
- Drug: Methotrexate
- label
- 2 mg LY3009104 twice daily
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1 mg LY3009104 once daily
- 2 mg LY3009104 once daily
- 2 mg LY3009104 twice daily
- 4 mg LY3009104 once daily
- 8 mg LY3009104 once daily
- description
- Administered orally
- name
- LY3009104
- other Names
- Janus Kinase (JAK)1/JAK2 Inhibitor
- JAK1/2 Inhibitor
- INCB028050
- baricitinib
- type
- DRUG
- arm Group Labels
- Placebo once daily
- description
- Administered orally
- name
- Placebo
- type
- DRUG
- arm Group Labels
- 1 mg LY3009104 once daily
- 2 mg LY3009104 once daily
- 2 mg LY3009104 twice daily
- 4 mg LY3009104 once daily
- 8 mg LY3009104 once daily
- Placebo once daily
- description
- Administered orally as background therapy
- name
- Methotrexate
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 301
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.
- measure
- Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12
- time Frame
- Baseline through Week 12
- secondary Outcomes
- description
- ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.
- measure
- Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response
- time Frame
- Baseline through Week 12
- description
- ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) \* 100.
- measure
- Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24
- time Frame
- Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
- description
- ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.
- measure
- Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128
- time Frame
- Baseline through Weeks 76 and 128
- description
- ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100.
- measure
- Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24
- time Frame
- Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
- description
- ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100.
- measure
- Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128
- time Frame
- Baseline through Weeks 76 and 128
- description
- ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100.
- measure
- Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24
- time Frame
- Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
- description
- ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100.
- measure
- Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128
- time Frame
- Baseline through Weeks 76 and 128
- description
- ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.
- measure
- Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response
- time Frame
- Baseline through Week 12
- description
- ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of a) % of improvement in TJC, b) % of improvement in SJC, and c) third highest percentage of improvement of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to a range of -100 to 100 to minimize impact of outliers (greater scores indicate greater % improvement) and negative scores indicate a decline. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.
- measure
- ACR Percent Improvement (ACR-N)
- time Frame
- Baseline through Week 12
- description
- TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
- measure
- Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)
- time Frame
- Baseline, Weeks 12 and 24
- description
- TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
- measure
- Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC
- time Frame
- Baseline, Weeks 76 and 128
- description
- The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
- measure
- Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
- time Frame
- Baseline, Weeks 12 and 24
Full study description
- brief Summary
- The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).
- detailed Description
- This study consists of the following: * Screening period: 4 to 28-days * Part A: a 12-week blinded, placebo controlled treatment period * Part B: a 12-week blinded extension period * Part C: an optional 52-week open-label extension period * Part D: an additional optional 52-week open-label extension period * Follow up period: 28 days
Source references
- references
- citation
- Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
- pmid
- 34706874
- type
- DERIVED
- citation
- Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.
- pmid
- 30842122
- type
- DERIVED
- citation
- Peterfy C, DiCarlo J, Emery P, Genovese MC, Keystone EC, Taylor PC, Schlichting DE, Beattie SD, Luchi M, Macias W. MRI and Dose Selection in a Phase II Trial of Baricitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis. J Rheumatol. 2019 Aug;46(8):887-895. doi: 10.3899/jrheum.171469. Epub 2019 Jan 15.
- pmid
- 30647190
- type
- DERIVED
- citation
- Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
- pmid
- 29463520
- type
- DERIVED
- citation
- Keystone EC, Genovese MC, Schlichting DE, de la Torre I, Beattie SD, Rooney TP, Taylor PC. Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. J Rheumatol. 2018 Jan;45(1):14-21. doi: 10.3899/jrheum.161161. Epub 2017 Aug 15.
- pmid
- 28811354
- type
- DERIVED
- citation
- Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, Lee CH, Fidelus-Gort RK, Luchi ME, Rooney TP, Macias WL, Genovese MC. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Ann Rheum Dis. 2015 Feb;74(2):333-40. doi: 10.1136/annrheumdis-2014-206478. Epub 2014 Nov 27.
- pmid
- 25431052
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- hritis (RA). Although other doses have been studied, the recommended dosage of OLUMIANT is 2 mg once daily. Dose-Ranging Studies The dose-ranging studies RA-1 (NCT01185353) and RA-2 (NCT01469013) included a 12-week randomized comparison of baricitinib 1, 2, 4, and 8 mg orally once daily versus placebo in 301 and 145 patients, res
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Preserved source evidence · Not medical advice