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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576433
First received: December 18, 2007
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


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

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 Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, including infusion-related adverse events [ Time Frame: For 48 weeks after initial treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of re-treatment (AEs) [ Time Frame: For 24 weeks after re-treatment. ] [ Designated as safety issue: No ]
  • Laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT. [ Time Frame: For 48 weeks after initial treatment. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: Methotrexate
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00576433

Locations
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576433     History of Changes
Other Study ID Numbers: ML21271
Study First Received: December 18, 2007
Last Updated: August 4, 2014
Health Authority: Russia: Federal Agency of Drug Quality Control

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Rituximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014