A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1

• Conditions: Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease; MedDRA version: 12.0Level: LLTClassification code 10036370Term: Posterior uveitis

• Registration Number: EUCTR2009-013901-33-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Population: Patients with intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease enrolled in the core study. In the extension study patients may elect to continue study treatments (Group 1) or only to complete the treatment-free safety follow-up period (Group 2).
Inclusion for Group 1:
•Patients who have completed the entire treatment period of the 24-week core study
•Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed.
Inclusion for Group 2:
•Patients who were randomized into 24-week core study and did not complete the treatment period or will not continue in the extension treatment phase.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion for Group 1:
•Inability or unwillingness to undergo repeated subcutaneous injections
•Inability to comply with study or follow-up procedures.
•Any medical or psychiatric condition which, in the investigator’s opinion would preclude the participant from adhering to the protocol or completing the study per protocol.
•Active systemic infections during the last two weeks (exception: common cold) prior Visit16 that in the opinion of the study investigator or sponsor that would be a contraindication to additional treatment with AIN457.
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
•Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant

There are no Exclusion criteria for Group 2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified