Conditions: Uveitis
Keywords: Uveitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 261
Healthy volunteers: no

Brief summary:
A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19. arm 2: Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.

Interventions: intervention 1: Adalimumab intervention 2: Prednisone intervention 3: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by 40 mg eow starting at Week 1. intervention 2: Administered orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all subjects continuing in the study were to discontinue prednisone no later than Week 19. intervention 3: Administered by subcutaneous injection

Protocol document: