Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642 AM2) (GO-AHEAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01453725
First received: October 13, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

This two-part study will evaluate the effect of golimumab in participants with active axial spondyloarthritis. In Part 1, participants will receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study participants will not know the identity of the injection. In the Part 2 extension all participants receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2 the participants will be told they are receiving active study drug.


Condition Intervention Phase
Spondylitis, Ankylosing
Drug: Golimumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Meeting the Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Meeting the Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Number of Participants in ASAS Partial Remission at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacro-iliac Joints Scoring from Baseline [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab
Part 1 of the study is blinded. Participants will receive open-label golimumab beginning at Week 16 (Part 2)
Drug: Golimumab
50 mg subcutaneous injection every 4 weeks
Placebo Comparator: Placebo
Part 1 of the study is blinded. Participants will receive open-label golimumab beginning at Week 16 (Part 2)
Drug: Placebo
Placebo subcutaneous injection every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)-α 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01453725     History of Changes
Other Study ID Numbers: P07642, MK-8259-006; 2011-000311-34
Study First Received: October 13, 2011
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on April 17, 2014