drugset / Trial / NCT01244958
Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven synergistic effects in patients with either lymphoma or autoimmune diseases. First data of uncontrolled trials with the combination of RTX and leflunomide (LEF) are available.
Timeline
- Start
- 2010-08
- Primary completion
- 2015-02
- Completion
- 2015-02
Publications
- Koehm M, Foldenauer AC, Rossmanith T, Alten R, Aringer M, Backhaus M, Burmester GR, Feist E, Kellner H, Krueger K, Muller-Ladner U, Rubbert-Roth A, Tony HP, Wassenberg S, Burkhardt H, Behrens F. Effectiveness of Different Rituximab Doses Combined with Leflunomide in the Treatment or Retreatment of Rheumatoid Arthritis: Part 2 of a Randomized, Placebo-Controlled, Investigator-Initiated Clinical Trial (AMARA). J Clin Med. 2022 Dec 9;11(24):7316. doi: 10.3390/jcm11247316.
- Behrens F, Koehm M, Rossmanith T, Alten R, Aringer M, Backhaus M, Burmester GR, Feist E, Herrmann E, Kellner H, Krueger K, Lehn A, Muller-Ladner U, Rubbert-Roth A, Tony HP, Wassenberg S, Burkhardt H. Rituximab plus leflunomide in rheumatoid arthritis: a randomized, placebo-controlled, investigator-initiated clinical trial (AMARA study). Rheumatology (Oxford). 2021 Nov 3;60(11):5318-5328. doi: 10.1093/rheumatology/keab153.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 500 mg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |