Clinical trial NCT01453725: Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
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-8259-006-02).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondylitis, Ankylosing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson
First posted: 2011-10-18
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to 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 were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.


Eligibility 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) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs
* 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

Primary outcomes:
measure: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
measure: Percentage of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2
Secondary outcomes:
measure: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving ASAS Partial Remission at Week 16
timeFrame: Week 16
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Sieper J, van der Heijde D, Dougados M, Maksymowych WP, Scott BB, Boice JA, Berd Y, Bergman G, Curtis S, Tzontcheva A, Huyck S, Weng HH. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015 Oct;67(10):2702-12. doi: 10.1002/art.39257.
citation: van der Heijde D, Dougados M, Maksymowych WP, Bergman G, Curtis SP, Tzontcheva A, Huyck S, Philip G, Sieper J. Long-term tolerability and efficacy of golimumab in active non-radiographic axial spondyloarthritis: results from open-label extension. Rheumatology (Oxford). 2022 Feb 2;61(2):617-627. doi: 10.1093/rheumatology/keab346.