Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)

NCT ID: NCT01453725

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-13
• Study Completion Date: 2015-01-15

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.

Conditions

Spondylitis, Ankylosing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Golimumab→Golimumab

In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: BIOLOGICAL

Golimumab 50 mg SC injection every 4 weeks

Placebo→Golimumab

In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

Group Type: PLACEBO_COMPARATOR

Golimumab

Intervention Type: BIOLOGICAL

Golimumab 50 mg SC injection every 4 weeks

Placebo

Intervention Type: BIOLOGICAL

Placebo SC injection every 4 weeks

Interventions

Golimumab

Golimumab 50 mg SC injection every 4 weeks

Intervention Type: BIOLOGICAL

Placebo

Placebo SC injection every 4 weeks

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26139307 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33878154 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-8259-006

Identifier Type: OTHER

Identifier Source: secondary_id

2011-000311-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P07642

Identifier Type: -

Identifier Source: org_study_id