A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD and/or Anti-TNF Therapy.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: July 17, 2007
Last updated: February 1, 2016
Last verified: February 2016
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to prior treatment with DMARDs and/or one anti-TNF alpha agent. Patients will be treated with MabThera (1000mg i.v.) on days 1 and 15; they may receive concomitant treatment with DMARDs, corticosteroids, NSAIDs and analgesics throughout the study period. After week 36, eligible patients may receive re-treatment with MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 200 individuals.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: rituximab [MabThera/Rituxan]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse events, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Categorical DAS responders [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in bone density [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: June 2005
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • rheumatoid arthritis;
  • inadequate response to previous or current treatment with DMARDs and/or 1 anti-TNF agent.

Exclusion Criteria:

  • rheumatic autoimmune disease or inflammatory joint disease other than RA;
  • concurrent treatment with an anti-TNF alpha therapy;
  • active infection or significant uncontrolled disease or malignancy.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503425

Ashkelon, Israel, 78306
Beer Sheva, Israel, 8410101
Beer Yaakov, Israel, 6093000
Hadera, Israel, 38100
Haifa, Israel, 3109601
Haifa, Israel, 3339419
Haifa, Israel, 34362
Holon, Israel, 58100
Jerusalem, Israel, 91240
Kfar Saba, Israel, 44281
Naharia, Israel, 22100
Nahariya, Israel, 22100
Nazareth, Israel, 16100
Petach Tikva, Israel, 4941492
Rehovot, Israel, 76100
Tel Aviv, Israel, 6423906
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00503425     History of Changes
Other Study ID Numbers: ML18606 
Study First Received: July 17, 2007
Last Updated: February 1, 2016
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016