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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2013 |
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Main ID: |
NCT01453725 |
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Date of registration:
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13/10/2011 |
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Primary sponsor: |
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Public title:
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Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642 AM2)
GO-AHEAD |
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Scientific title:
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-00). |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01453725 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Czech Republic
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Denmark
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Finland
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Germany
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Greece
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Ireland
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Italy
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Russian Federation
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Slovakia
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Spain
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Toll Free Number |
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Address:
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Telephone:
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1-888-577-8839 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Active axial spondyloarthritis with disease duration =5 years, and chronic back pain
of =3 month duration
- Have either an inadequate response to 30 days of optimal daily doses of at least one
non-steroidal anti-inflammatory drug (NSAID)
- Females of child-bearing potential must use contraception
- No history of untreated latent or active tuberculosis
Exclusion Criteria:
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Has ever received tumor necrosis factor (TNF)-a targeted therapy or any biological
agents
- Any systemic inflammatory condition other than spondyloarthritis
- Serious infection within 2 months
- Any known malignancy or a history of malignancy within the previous 5 years
- Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spondylitis, Ankylosing
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Intervention(s)
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Drug: Golimumab
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Drug: Placebo
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Primary Outcome(s)
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Number of Participants Meeting the Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
[Time Frame: Week 16]
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Secondary Outcome(s)
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Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacro-iliac Joints Scoring from Baseline
[Time Frame: Baseline and Week 16]
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Number of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
[Time Frame: Week 16]
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Number of Participants in ASAS Partial Remission at Week 16
[Time Frame: Week 16]
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Number of Participants Meeting the Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
[Time Frame: Week 16]
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Secondary ID(s)
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MK-8259-006; 2011-000311-34
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P07642
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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