A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis

Conditions

• Spondylitis, Ankylosing

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• golimumab — BIOLOGICAL
  100 mg sc injections every 4 wks from wk 0 up to 5 yrs
• Golimumab (CNTO 148); placebo — BIOLOGICAL
  SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg
• golimumab — BIOLOGICAL
  50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg

Study Details

The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

Key Dates

Start date

Dec 31, 2005

Status verified

Jul 2013

Primary completion

Mar 31, 2007

Completion

Jan 31, 2012

Study Design

Enrollment

356 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 003
  golimumab 100 mg sc injections every 4 wks from wk 0 up to 5 yrs
• Placebo Comparator: 001
  Golimumab (CNTO 148); placebo SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg
• Experimental: 002
  golimumab 50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg

Primary Outcome Measure

Assessment in Ankylosing Spondylitis 20 Responders at Week 14 [ Time Frame: Week 14 ]

Locations (11)

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• Natural History and Development of Spondyloarthritis
  Recruiting · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Bethesda, Maryland