A Study of Golimumab in Participants With Active Ankylosing Spondylitis

Conditions

• Ankylosing Spondylitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Participants will receive matching placebo.
• Golimumab — DRUG
  Participants will receive 2mg/kg of intravenous infusions of golimumab .

Study Details

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).

Key Dates

Start date

Sep 3, 2014

Status verified

Oct 2025

Primary completion

Dec 15, 2015

Completion

Oct 11, 2016

Study Design

Enrollment

208 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group 1: Placebo then Golimumab
  Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.
• Experimental: Treatment Group 2: Golimumab
  Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.

Primary Outcome Measure

Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 [ Time Frame: Week 16 ]

Locations (11)

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