Conditions: Uveitis
Keywords: inflammation of uvea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: no

Brief summary:
A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.

Detailed description:

Arms:
arm 1: Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. arm 2: Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.

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 a 40 mg dose eow starting at Week 1. intervention 2: Administered orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all participants continuing in the study were to discontinue prednisone no later than Week 15. intervention 3: Administered by subcutaneous injection

Protocol document: