An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-TNF Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00883753
First received: April 17, 2009
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

This study is an extension to study MA21573, which is an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs, in patients with moderate to severe active rheumatoid arthritis. Patients who complete the 24 week core study, and have at least a moderate response, are eligible to enter this long-term extension study, and will receive tocilizumab 8mg/kg iv every 4 weeks.The anticipated time on study treatment is 1-2 years, and the target sample size is >500 individuals.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
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 Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of AEs and SAEs [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment discontinuations overall and by TNF antagonist use;incidence of AEs of special interest [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
  • Incidence of LFT and lipid abnormalities [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Clinically meaningful improvement (reduction of >=1.2 units) in DAS28; low DAS28(<3.2) and time to low DAS28 [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • ACR20/50/70 response; HAQ; SF-36; FACIT-Fatigue score [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 926
Study Start Date: March 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for up to 104 weeks

  Eligibility

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

Inclusion Criteria:

  • patients who have completed 24 weeks treatment on study MA21573 and have had at least a moderate response(EULAR criteria);

Exclusion Criteria:

  • as for MA21573
  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: NCT00883753

  Show 171 Study Locations
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: NCT00883753     History of Changes
Other Study ID Numbers: MA22460, 2008-006924-68
Study First Received: April 17, 2009
Last Updated: October 28, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014