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: June 24, 2014
Last verified: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 24, 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 July 22, 2014