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

July 22, 2008
May 13, 2013
September 2005
August 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00720798 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Quality of life: The HAQ, SF 36, EQ-5D, FACIT fatigue scale [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Extension Study of Tocilizumab in Patients Completing Treatment in Tocilizumab Core Studies
Long-term Extension Study of Safety During Treatment With Tocilizumab in Rheumatoid Arthritis Patients Completing Treatment in Tocilizumab Core Studies WA18062, WA18063 and WA17824

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: tocilizumab [RoActemra/Actemra]
    iv 8mg/kg every 4 weeks
  • Drug: Standard anti-rheumatic treatment
    As prescribed
Experimental: 1
Interventions:
  • Drug: tocilizumab [RoActemra/Actemra]
  • Drug: Standard anti-rheumatic treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2068
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Costa Rica,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Iceland,   Israel,   Italy,   Lithuania,   Mexico,   Netherlands,   Norway,   Panama,   Peru,   Portugal,   Puerto Rico,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom
 
NCT00720798
WA18696
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP