A Study of Tocilizumab in Patients Completing Treatment in WA17822 - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00721123

Purpose

This single arm study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab WA17822 study 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 Drug: Standard anti-rheumatic treatment	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Extension Study of Safety During Treatment With Tocilizumab in Rheumatoid Arthritis Patients Completing Treatment in WA17822

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Efficacy: Concomitant corticosteroid treatment;proportion of patients with ACR20, ACR50 and ACR70 response; individual components of the ACR core set; withdrawals from treatment. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
Efficacy: Change in DAS28, categorical DAS responders; maintenance of ACR20, ACR50 and ACR70 response. [ Time Frame: 24, 48, 96 and 264 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life: The HAQ, Short Form 36, EQ-5D and FACIT fatigue scale. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	630
Study Start Date:	August 2005
Estimated Study Completion Date:	May 2012

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 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 the Phase III study WA17822 in adult rheumatoid arthritis.

Exclusion Criteria:

treatment with any investigational agent since the last administration of study drug in WA17822;
treatment with iv gammaglobulin, plasmapheresis or Prosorba column since the last administration of study drug in WA17822;
treatment with an anti-TNF of anti-IL1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822;
previous treatment with any cell-depleting therapies;
parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18695.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721123

Show 70 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WA18695
Study First Received:	July 22, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00721123
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009