Clinical trial NCT02897115: A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment
Official title: STRIKE - Treating Patients With Early Axial Spondyloarthritis to Target - a 1 Year Randomized Controlled Study Taking an Intense Treatment Approach Versus Routine Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Axial Spondyloarthritis
Keywords: Axial Spondyloarthritis
Humira
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: IST GmbH, Germany
name: Hannover Medical School
name: Improvement by Movement GmbH, Germany
First posted: 2016-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32
timeFrame: Week 32
Secondary outcomes:
measure: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Presenteeism
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Absenteeism
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Work Productivity Impairment
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Activity Impairment
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: Baseline, week 32, and week 52
measure: Percentage of Participants Achieving a BASDAI 50 Response
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in ASDAS(CRP)
timeFrame: Baseline, week 32, and week 52
measure: Percentage of Participants Achieving ASDAS(CRP) Major Improvement
timeFrame: Baseline, week 32, and week 52
measure: Percentage of Participants Achieving ASDAS(CRP) Clinically Important Improvement
timeFrame: Baseline, week 32, and week 52
measure: Percentage of Participants With ASDAS Inactive Disease at Week 52
timeFrame: Week 52
measure: Percentage of Participants With ASDAS Low Disease Activity
timeFrame: Week 32 and week 52
measure: Percentage of Participants With ASDAS Moderate Disease Activity
timeFrame: Week 32 and week 52
measure: Percentage of Participants With ASDAS High Disease Activity
timeFrame: Week 32 and week 52
measure: Percentage of Participants With ASDAS Very High Disease Activity
timeFrame: Week 32 and week 52
measure: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
timeFrame: Baseline, week 32, and week 52
measure: Percentage of Participants Achieving an ASAS 40 Response
timeFrame: Baseline, week 32, and week 52
measure: Percentage of Participants Achieving ASAS Partial Remission
timeFrame: Week 32 and week 52
measure: Change From Baseline in Active Inflammation of the Sacroiliac Joints and Spine
timeFrame: Baseline and week 52
measure: Change From Baseline in Physician's Global Assessment of Disease Activity
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Patient's Global Assessment of Disease Activity
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Patient's Global Assessment of Pain
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Swollen Joint Count
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Tender Joint Count
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES)
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Dactylitis Count
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: Baseline, week 32, and week 52
measure: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin)
timeFrame: Baseline, week 32, and week 52
measure: Number of Participants With New Onset Anterior Uveitis
timeFrame: Up to Week 52
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: