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

NCT01453725 | Completed Phase 3 Results

• 3 other identifiers: P07642MK-8259-0062011-000311-34
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16

  The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of \>=20% from Baseline and an absolute improvement from Baseline of \>=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a \>=20% worsening and an absolute worsening of \>=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.

  Week 16

• Percentage of Participants Who Experienced at Least One Adverse Event (AE)

  An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.

  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)

• Percentage of Participants Who Discontinued Study Drug Due to an AE

  An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.

  Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2

Secondary Outcomes (4)

• Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16

  Week 16

• Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16

  Week 16

• Percentage of Participants Achieving ASAS Partial Remission at Week 16

  Week 16

• Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16

  Baseline and Week 16

Study Arms (2)

Golimumab→Golimumab

EXPERIMENTAL

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.)

Biological: Golimumab

Placebo→Golimumab

PLACEBO COMPARATOR

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.)

Biological: Golimumab; Biological: Placebo

Interventions

Golimumab BIOLOGICAL

Golimumab 50 mg SC injection every 4 weeks

Golimumab→Golimumab; Placebo→Golimumab

Placebo BIOLOGICAL

Placebo SC injection every 4 weeks

Placebo→Golimumab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Johnson & Johnson: collaborator

Related Publications (2)

• 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.

  PMID: 26139307 RESULT

• 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.

  PMID: 33878154 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

golimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: February 13, 2012
• Primary Completion: March 11, 2014
• Study Completion: January 15, 2015
• Last Updated: February 6, 2019
• Results First Posted: December 18, 2014

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share