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

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: NCT00424502
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : July 14, 2014
Last Update Posted : May 9, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
Study Start Date : January 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
Other Name: MabThera/Rituxan

Drug: Methotrexate
10-25mg po/week

Primary Outcome Measures :
  1. Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Day 0 and Week 24 ]
    DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.

Secondary Outcome Measures :
  1. Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores [ Time Frame: Day 0 and Week 24 ]
    The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).

  2. Anti-cyclic Citrullinated Peptide (Anti-CCP) [ Time Frame: Day 0 and Week 24 ]
    Anti-CCP measured as absorbance units per milliliter (AU/mL).

  3. Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Day 0 and Week 24 ]
    VEGF was measured as picograms per milliliter (pg/mL).

  4. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Day 0 and Week 24 ]
    ESR was measured in mm/hr.

  5. C-Reactive Protein (CRP) [ Time Frame: Day 0 and Week 24 ]
    CRP was measured in milligrams per liter (mg/L).

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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;
  • diagnosed RA for >=3 months prior to first administration of study medication;
  • inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
  • if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.

Exclusion Criteria:

  • other chronic inflammatory diseases;
  • use of parental corticosteroids within 4 weeks prior to screening;
  • severe heart failure, or severe, uncontrolled cardiac disease.

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): NCT00424502

Budapest, Hungary, 1023
Budapest, Hungary, 1027
Debrecen, Hungary, 4032
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00424502     History of Changes
Other Study ID Numbers: ML20538
First Posted: January 19, 2007    Key Record Dates
Results First Posted: July 14, 2014
Last Update Posted: May 9, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
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