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A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

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: NCT00504777
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. 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: rituximab [MabThera/Rituxan] Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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 Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.
Study Start Date : July 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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

Drug: Methotrexate
10-25mg/week po or parenteral

Primary Outcome Measures :
  1. Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Week 24 ]
    DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.

Secondary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology (ACR) Response [ Time Frame: Week 24 ]
    ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).

  2. Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category [ Time Frame: Week 24 ]
    Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.

  3. Change From Baseline in HAQ-DI Score [ Time Frame: Week 24 ]
    The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent "mild to moderate difficulty", 1 to 2 as "moderate to severe disability", and 2 to 3 as "severe to very severe disability".

Information from the National Library of Medicine

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • active rheumatoid arthritis;
  • receiving outpatient treatment;
  • an inadequate response, or intolerance, to >=1 anti-TNF agent.

Exclusion Criteria:

  • other rheumatic autoimmune disease or inflammatory joint disease;
  • concurrent treatment with any anti-TNF-alpha therapy;
  • joint or osseous surgery during 8 weeks prior to recruitment.

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): NCT00504777

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Changhua, Taiwan, 500
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 807
Kaohsiung, Taiwan, 813
Taichung, Taiwan, 402
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Taipei, Taiwan, 00112
Taoyuan, Taiwan, 333
Tapei, Taiwan, 114
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: NCT00504777    
Other Study ID Numbers: ML20798
First Posted: July 20, 2007    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014
Last Verified: July 2014
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