A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment (STRIKE)

AbbVie

Status and phase: Terminated; Phase 4

Conditions: Axial Spondyloarthritis

Treatments: Other: Non-steroidal Anti-inflammatory Drugs (NSAIDs); Biological: Adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02897115

2015-005398-18 (EudraCT Number)

W15-679

Details and patient eligibility

About

A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment (Standard of Care [SOC]) in reducing disease activity in participants with axial spondyloarthritis (axSpA).

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent before start of study-related assessments or procedures
• Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA
• Participants aged ≥ 18 years
• Disease duration < 5 years
• Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a Bath AS Disease Activity Index (BASDAI) ≥ 4
• NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2 weeks prior to the Baseline visit
• Participants must never have failed a NSAID taken at maximal recommended dose for 2 weeks or more.

Exclusion criteria

• Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local labeling
• If entering the study on concomitant NSAIDs, participants taking the maximal recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time
• Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or participant has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Treat-to-Target (T2T)

Experimental group

Description:

Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2 or treatment with the chosen NSAID was not tolerated, , participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.

Treatment:

Biological: Adalimumab

Standard of Care (SOC)

Active Comparator group

Description:

Participants received treatment as prescribed by their physician according to the local standard of care.

Treatment:

Other: Non-steroidal Anti-inflammatory Drugs (NSAIDs)