TriangleNCT00299130 · CITED IN SOURCE DOCUMENTS
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-04-17
This study evaluated the efficacy and safety of rituximab in patients with active 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 With American College of Rheumatology (ACR) 20 Response at Week 24
Percentage of Participants With an ACR50 Response at Week 24
Percentage of Participants With an ACR70 Response at Week 24
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
Percent Change From Baseline in Swollen Joint Count
Percent Change From Baseline in Tender Joint Count
Percent Change From Baseline in Patient's Global Assessment of Disease Activity
Percent Change From Baseline in Patient's Pain Assessment
Percent Change From Baseline in Physician's Global Assessment of Disease Activity
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Percent Change From Baseline in C-Reactive Protein
Percent Change From Baseline in Erythrocyte Sedimentation Rate
Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)
Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score
Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores
Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24
Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24
Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48
Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48
Percentage of Participants With an ACR50 Response at Week 48
Percentage of Participants With an ACR70 Response at Week 48
Time to Repletion of Peripheral CD19+ B-cells
Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion criteria: * Adult patients 18-80 years of age. * Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis. * Receiving outpatient treatment for RA. * Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline. * At screening, either * C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or * Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour. * Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks. Exclusion criteria: * Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA. * Inflammatory joint disease other than RA, or other systemic autoimmune disorder. * Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16. * Surgery within 12 weeks of study or planned within 24 weeks of randomization. * Previous treatment with any approved or investigational biological agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
- healthy Volunteers
- false
- maximum Age
- 80 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- intervention Names
- Drug: Folate
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Placebo
- Drug: Rituximab
- label
- Placebo + methotrexate (MTX)
- type
- ACTIVE_COMPARATOR
- description
- Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- intervention Names
- Drug: Folate
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Rituximab
- label
- Rituximab 2 x 0.5 g + MTX
- type
- EXPERIMENTAL
- description
- Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- intervention Names
- Drug: Folate
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Rituximab
- label
- Rituximab 2 x 1.0 g + MTX
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Placebo + methotrexate (MTX)
- Rituximab 2 x 0.5 g + MTX
- Rituximab 2 x 1.0 g + MTX
- description
- A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.
- name
- Folate
- type
- DRUG
- arm Group Labels
- Placebo + methotrexate (MTX)
- Rituximab 2 x 0.5 g + MTX
- Rituximab 2 x 1.0 g + MTX
- description
- A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.
- name
- Methotrexate
- type
- DRUG
- arm Group Labels
- Placebo + methotrexate (MTX)
- Rituximab 2 x 0.5 g + MTX
- Rituximab 2 x 1.0 g + MTX
- description
- Intravenous infusion
- name
- Methylprednisolone
- type
- DRUG
- arm Group Labels
- Placebo + methotrexate (MTX)
- description
- Placebo to rituximab intravenous infusion
- name
- Placebo
- type
- DRUG
- arm Group Labels
- Placebo + methotrexate (MTX)
- Rituximab 2 x 0.5 g + MTX
- Rituximab 2 x 1.0 g + MTX
- description
- Intravenous infusion
- name
- Rituximab
- other Names
- MabThera®
- Rituxan®
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 511
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 100 mm VAS); * Patient's assessment of pain (assessed using a 100 mm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR). Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders.
- measure
- Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
- time Frame
- Baseline and Week 24
- secondary Outcomes
- description
- To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 100 mm VAS); * Patient's assessment of pain (assessed using a 100 mm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR). Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders.
- measure
- Percentage of Participants With an ACR50 Response at Week 24
- time Frame
- Baseline and Week 24
- description
- To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 100 mm VAS); * Patient's assessment of pain (assessed using a 100 mm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR). Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders.
- measure
- Percentage of Participants With an ACR70 Response at Week 24
- time Frame
- Baseline and Week 24
- description
- The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * Erythrocyte sedimentation rate (ESR); * Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
- measure
- Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
- time Frame
- Baseline and Week 24
- description
- A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: * an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, * an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.
- measure
- Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
- time Frame
- Baseline and Week 24
- description
- Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Swollen Joint Count
- time Frame
- Baseline, Week 24 and Week 48
- description
- Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Tender Joint Count
- time Frame
- Baseline, Week 24 and Week 48
- description
- The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Patient's Global Assessment of Disease Activity
- time Frame
- Baseline, Week 24 and Week 48
- description
- The participant's assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand extreme (100 mm) as "unbearable pain". The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Patient's Pain Assessment
- time Frame
- Baseline, Week 24 and Week 48
- description
- The physician's assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity". The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Physician's Global Assessment of Disease Activity
- time Frame
- Baseline, Week 24 and Week 48
- description
- The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
- time Frame
- Baseline, Week 24 and Week 48
- description
- C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in C-Reactive Protein
- time Frame
- Baseline, Week 24 and Week 48
- description
- Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- measure
- Percent Change From Baseline in Erythrocyte Sedimentation Rate
- time Frame
- Baseline, Week 24 and Week 48
Full study description
- brief Summary
- This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).
Source references
- references
- citation
- Emery P, Deodhar A, Rigby WF, Isaacs JD, Combe B, Racewicz AJ, Latinis K, Abud-Mendoza C, Szczepanski LJ, Roschmann RA, Chen A, Armstrong GK, Douglass W, Tyrrell H. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis. 2010 Sep;69(9):1629-35. doi: 10.1136/ard.2009.119933. Epub 2010 May 20.
- pmid
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- type
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- citation
- Lal P, Su Z, Holweg CT, Silverman GJ, Schwartzman S, Kelman A, Read S, Spaniolo G, Monroe JG, Behrens TW, Townsend MJ. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment. Arthritis Rheum. 2011 Dec;63(12):3681-91. doi: 10.1002/art.30596.
- pmid
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- type
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Source notices and limitations
Discovery and provenance
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- elow reflect the experience in 2578 RA patients treated with RITUXAN in controlled and long-term studies Pooled studies: NCT00074438, NCT00422383, NCT00468546, NCT00299130, NCT00282308, NCT00266227, NCT02693210, NCT02093026 and NCT02097745. with a total exposure of 5014 patient-years. Among all exposed patients, adverse reactions
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Preserved source evidence · Not medical advice