Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01124838
Phase
PHASE3
Status
Completed

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by 40 mg eow starting at Week 1.
  • Prednisone — DRUG
    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.
  • Placebo — DRUG
    Administered by subcutaneous injection

Study Details

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

Key Dates

Start date
Aug 31, 2010
Status verified
Jul 2021
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
261 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    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.
  • Experimental: Adalimumab
    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.

Primary Outcome Measure

Time to Treatment Failure on or After Week 2 [ Time Frame: From Baseline until end of study (up to 80 weeks) ]

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