TriangleNCT02693210 · CITED IN SOURCE DOCUMENTS
A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis
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
- 2016-11-01
WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.
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.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Participants with moderate to severe rheumatoid arthritis (RA) who have previously failed 1-5 DMARDS who currently have partial clinical response to treatment with methotrexate * Using methotrexate as a single DMARD for at least 16 weeks, of which the last 4 weeks prior to baseline on a stable oral dose greater than or equal to (\>=) 10 milligrams per week (mg/week) * \>=21 years of age * Swollen Joint Count (SJC) and Tender Joint Count (TJC) \>= 8 (out of 66 and 68 joints respectively) * At least 2 of the following parameters at Baseline: C- Reactive Protein \>= 15 mg/dL; Erythrocyte Sedimentation Rate \>= 30 millimeters per hour (mm/hr); Morning stiffness \>45 minutes * Rheumatoid factor titer \>=20 International units per milliliter (IU/mL) * Corticosteroid (less than or equal to \[=\<\] 12.5 milligrams per deciliter \[mg/d\] prednisone or equivalent) or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are permitted if stable for at least 4 weeks prior to baseline Exclusion Criteria: * American Rheumatism Association (ARA) Class IV RA disease * Concurrent treatment with any DMARD (apart from randomized treatment) or anti-TNF-alpha therapy * Active infection or history of recurrent significant infection * Prior history of cancer including solid tumors and hematologic malignancies (except basal carcinoma of the skin that have been excised and cured) * Evidence of serious uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders * Bone/joint surgery within 6 weeks prior to screening * Rheumatic Autoimmune disease other than RA * Active rheumatoid vasculitis * Prior history of gout * Chronic fatigue syndrome
- healthy Volunteers
- false
- minimum Age
- 21 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive methotrexate at dosage \>=10 milligrams per week (mg/week) orally as determined by the investigator. They also receive placebo infusion on days 1 and 15 in place of rituximab and on Days 3 and 17 in place of cyclophosphamide.
- intervention Names
- Drug: Methotrexate
- Other: Placebo Cyclophosphamide
- Other: Placebo Rituximab
- label
- Group A: Methotrexate
- type
- ACTIVE_COMPARATOR
- description
- Participants will receive 1 g intravenous infusions of rituximab on Days 1 and 15. They also receive Weekly placebo orally instead of methotrexate and placebo infusion in place of cyclophosphamide on Days 3 and 17.
- intervention Names
- Other: Placebo Cyclophosphamide
- Other: Placebo Methotrexate
- Drug: Rituximab
- label
- Group B: Rituximab Monotherapy
- type
- EXPERIMENTAL
- description
- Participants will receive 1g IV infusion of rituximab on Days 1 and 15 and 750 mg infusion of Cyclophosphamide on Days 3 and 17. They also receive weekly oral placebo in place of methotrexate.
- intervention Names
- Drug: Cyclophosphamide
- Other: Placebo Methotrexate
- Drug: Rituximab
- label
- Group C: Rituximab and Cyclophosphamide
- type
- EXPERIMENTAL
- description
- Participants will receive \>=10 mg/week methotrexate orally along with 2 times 1 gram (g) rituximab IV infusions on Days 1 and 15. Participants will also receive placebo infusions on Days 3 and 17 in place of cyclophosphamide.
- intervention Names
- Drug: Methotrexate
- Other: Placebo Cyclophosphamide
- Drug: Rituximab
- label
- Group D: Methotrexate and Rituximab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Group C: Rituximab and Cyclophosphamide
- description
- Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
- name
- Cyclophosphamide
- type
- DRUG
- arm Group Labels
- Group A: Methotrexate
- Group D: Methotrexate and Rituximab
- description
- Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks
- name
- Methotrexate
- type
- DRUG
- arm Group Labels
- Group A: Methotrexate
- Group B: Rituximab Monotherapy
- Group D: Methotrexate and Rituximab
- description
- Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
- name
- Placebo Cyclophosphamide
- type
- OTHER
- arm Group Labels
- Group B: Rituximab Monotherapy
- Group C: Rituximab and Cyclophosphamide
- description
- Participants will receive weekly oral placebo in place of Methotrexate
- name
- Placebo Methotrexate
- type
- OTHER
- arm Group Labels
- Group A: Methotrexate
- description
- Participants will receive placebo in place of rituximab on days 1 and 15
- name
- Placebo Rituximab
- type
- OTHER
- arm Group Labels
- Group B: Rituximab Monotherapy
- Group C: Rituximab and Cyclophosphamide
- Group D: Methotrexate and Rituximab
- description
- Participants will receive 1g infusions of rituximab on Days 1 and 15
- name
- Rituximab
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 161
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Percentage of participants achieving American College of Rheumatology (ACR) 50 response at Week 24
- time Frame
- Week 24
- secondary Outcomes
- measure
- Percentage of participants achieving ACR 20 and ACR 70 responses at Week 24
- time Frame
- Week 24
- measure
- Area Under the Curve (AUC) of American College of Rheumatology Response (ACRn)
- time Frame
- Baseline up to Week 24
- measure
- AUC of the mean Disease Activity Scores (DAS)
- time Frame
- Baseline up to Week 24
- measure
- Change from Baseline in the Swollen Joint Count
- time Frame
- Baseline, Weeks 12, 16, 20 and 24
- measure
- Change from Baseline in the Tender Joint Count
- time Frame
- Baseline, Weeks 12, 16, 20 and 24
- measure
- Change from Baseline in participant's global assessment of disease activity using a Visual Analog Scale (VAS)
- time Frame
- Baseline, Weeks 8, 12, 16, 20 and 24
- measure
- Change from Baseline in physician's global assessment of disease activity using VAS
- time Frame
- Baseline, Weeks 8, 12, 16, 20 and 24
- measure
- Change from Baseline in the Health Assessment Questionnaire - Disease Index (HAQ-DI) scores
- time Frame
- Baseline, Weeks 12, 16, 20 and 24
- measure
- Change from Baseline in participant's pain measured by VAS
- time Frame
- Baseline, Weeks 12, 16, 20 and 24
- measure
- Change from Baseline in C-Reactive Protein (CRP) Levels
- time Frame
- Baseline, Weeks 12, 16, 20 and 24
- measure
- Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
- time Frame
- Baseline, Weeks 12, 16, 20 and 24
- measure
- Mean change in Rheumatoid factor levels at 24 weeks
- time Frame
- Baseline and Week 24
Full study description
- brief Summary
- WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice