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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Biological: Golimumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01453725

P07642

2011-000311-34 (EudraCT Number)

MK-8259-006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups, including a placebo group

Golimumab→Golimumab

Experimental group

Description:

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.)

Treatment:

Biological: Golimumab

Placebo→Golimumab

Placebo Comparator group

Description:

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.)

Treatment:

Biological: Placebo

Biological: Golimumab