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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00503425
First received: July 17, 2007
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 48, eligible patients may receive re-treatment with MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 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

  Eligibility

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

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

Locations
Israel
Ashkelon, Israel, 78306
Beer Sheva, Israel, 8410101
Hadera, Israel, 38100
Haifa, Israel, 34362
Haifa, Israel, 34354
Haifa, Israel, 3339419
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
Rishon Lezion, Israel
Tel Aviv, Israel, 6423906
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: April 7, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014