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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00265083
• Date of registration: 12/12/2005
• Prospective Registration: No
• Primary sponsor: Centocor, Inc.
• Public title: A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis
• Date of first enrolment: December 2005
• Target sample size: 356
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00265083
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Finland, France, Germany, Korea, Republic of, Netherlands, Taiwan, United Kingdom, United States

Contacts

• Name: Centocor, Inc. Clinical Trial
• Affiliation: Centocor, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New
York criteria, for at least 3 months prior to first dose of study drug

- Symptoms of active disease at screening and at baseline visits, as evidenced by both a
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4, and a Total
Back Pain score of >= 4 (each on a scale of 0 to 10cm)

- Inadequate response to 3 months of continuous therapy with maximal recommended doses
of NSAIDs, or else unable to receive a full 3 months of maximal NSAID therapy because
of intolerance, toxicity, or contraindications to non-steroidal anti-inflammatory
drugs (NSAIDs)

- Stable doses of methotrexate, sulfasalazine, hydroxychloroquine, low-dose
corticosteroids, and NSAIDs are permitted.

Exclusion Criteria:

- Patients cannot have complete ankylosis of the spine

- No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Biological: golimumab

Biological: Golimumab (CNTO 148); placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14 [Time Frame: From Baseline to Week 14]

Assessment in Ankylosing Spondylitis 20 Responders at Week 24 [Time Frame: Week 24]

Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14 [Time Frame: From Baseline to Week 14]

Secondary ID(s)

CR006337

C0524T09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Schering-Plough

Results

• Results available: Yes
• Date Posted: 13/07/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00265083