An Extension Study of Tocilizumab in Patients Completing Treatment in Tocilizumab Core Studies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00720798
First received: July 22, 2008
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

This single arm study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab core studies of adults with rheumatoid arthritis. Patients will receive tocilizumab alone or in combination with standard anti-rheumatic treatment. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Drug: Standard anti-rheumatic treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Extension Study of Safety During Treatment With Tocilizumab in Rheumatoid Arthritis Patients Completing Treatment in Tocilizumab Core Studies WA18062, WA18063 and WA17824

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Concomitant corticosteroid treatment; proportion of patients with ACR20/50/70 response; individual components of the ACR core set; withdrawals from treatment. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Change in DAS28; categorical DAS responders; maintenance of ACR20/50/70 response. [ Time Frame: 24, 48, 96, 264 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: The HAQ, SF 36, EQ-5D, FACIT fatigue scale\n [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 2068
Study Start Date: September 2005
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
iv 8mg/kg every 4 weeks
Drug: Standard anti-rheumatic treatment
As prescribed

  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 participation in one of the core studies in adult rheumatoid arthritis.

Exclusion Criteria:

  • treatment with any investigational agent since the last administration of study drug in core studies;
  • treatment with iv gamma globulin, plasmapheresis or prosorba column since the last administration of study drug in core studies;
  • treatment with an anti-TNF or anti-IL1 agent, or a T-cell costimulation modulator or any biologic since the last administration of study drug in core studies;
  • previous treatment with any cell-depleting therapies, including investigational agents;
  • parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18696.
  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: NCT00720798

  Show 295 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: NCT00720798     History of Changes
Other Study ID Numbers: WA18696
Study First Received: July 22, 2008
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

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 September 22, 2014