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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576433
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate Drug: rituximab [MabThera/Rituxan] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor
Study Start Date : December 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: 1 Drug: Methotrexate
As prescribed

Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15

Primary Outcome Measures :
  1. AEs, including infusion-related adverse events [ Time Frame: For 48 weeks after initial treatment ]

Secondary Outcome Measures :
  1. Safety of re-treatment (AEs) [ Time Frame: For 24 weeks after re-treatment. ]
  2. Laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  3. ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT. [ Time Frame: For 48 weeks after initial treatment. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • moderate to severe active rheumatoid arthritis;
  • inadequate response to previous or current treatment with 1 anti-TNF agent;
  • receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.

Exclusion Criteria:

  • previous treatment with MabThera;
  • use of an anti-TNF alpha agent within 8 weeks of study start;
  • concurrent treatment with any DMARD other than methotrexate;
  • active infection, or history of serious recurrent or chronic infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576433

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Russian Federation
Chelyabinsk, Russian Federation, 454076
Ekaterinburg, Russian Federation, 620102
Irkutsk, Russian Federation, 664047
Kazan, Russian Federation, 420012
Khabarovsk, Russian Federation, 680009
Khanty-Mansiysk, Russian Federation, 628011
Kursk, Russian Federation, 305007
Moscow, Russian Federation, 115522
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630099
Novosibirsk, Russian Federation, 630117
Ryazan, Russian Federation, 390026
Saint-Petersburg, Russian Federation, 195067
Tjumen, Russian Federation, 625023
UFA, Russian Federation, 450005
Vladivostok, Russian Federation, 690050
Voronezh, Russian Federation, 394066
Yaroslavl, Russian Federation, 150062
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT00576433    
Other Study ID Numbers: ML21271
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors