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Clinical Trials/EUCTR2005-002909-23-SE
EUCTR2005-002909-23-SEActive, not recruitingNot Applicable

ong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96

F Hoffmann La-Roche Ltd.0 sites2,420 target enrollmentStarted: December 23, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
2,420
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •patients who have completed participation in one of the core studies (e.g. WA17824, WA18062, WA18063, and WP18663) in adult rheumatoid arthritis.
  • •inadequate response to a stable dose of MTX or other allowable Disease Modifying Anti-Rheumatic Drug (DMARD).
  • •patients of reproductive potential must be using reliable methods of contraception.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 1711
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 357

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-tumor necrosis factor agent or anti-IL-1 agent, or a T-cell costimulation modulator or any biologic since the last administration of study drug in the core studies.

Investigators

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