Cyclophosphamide
DrugParticipants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
NCT Number: NCT02693210
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.
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Notify Me21 year and older
All sexes
Interventional
Phase 2
Darlinghurst, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
Participants will receive >= 10 mg/week methotrexate orally up to 24 weeks
Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
Participants will receive weekly oral placebo in place of Methotrexate
Participants will receive placebo in place of rituximab on days 1 and 15
Participants will receive 1g infusions of rituximab on Days 1 and 15
Time frame: Week 24
Time frame: Week 24
Time frame: Baseline up to Week 24
Time frame: Baseline up to Week 24
Time frame: Baseline, Weeks 12, 16, 20 and 24
Time frame: Baseline, Weeks 12, 16, 20 and 24
Time frame: Baseline, Weeks 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 12, 16, 20 and 24
Time frame: Baseline, Weeks 12, 16, 20 and 24
Time frame: Baseline, Weeks 12, 16, 20 and 24
Time frame: Baseline, Weeks 12, 16, 20 and 24
Time frame: Baseline and Week 24
Time frame: Up to 24 Weeks
Hoffmann-La Roche
Industry
A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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