Treating patients with early axial spondyloarthritis to target – a 1 year randomized controlled study taking an intense treatment approach versus routine treatment (STRIKE)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005398-18-DE

Enrollment

240

Registered

2016-03-16

Start date

2016-07-12

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial spondyloarthritis MedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of axial SpA (either ankylosing spondylitis or non-radiographic axial SpA) and fulfilling the ASAS classification criteria for axial SpA 2. Subjects aged = 18 years 3. Disease duration =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: 1. Contraindications for NSAIDs or Tumor Necrosis Factor (TNF) blocker according to local labeling 2. If entering the study on concomitant NSAIDs, subjects taking the maximal recommended dose during the 2 weeks prior to Baseline or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time 3. Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or subject 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare a treat-to-target (T2T) intense treatment approach with a routine treatment approach (Standard of Care [SOC]) in reducing disease activity at week 32 in patients with axial spondyloarthritis (axSpA).;Secondary Objective: To compare a T2T intense treatment approach with SOC by assessing the following: improvement of quality of life, improvement of function, improvement of work productivity, reducing inflammation, reducing disease activity;Primary end point(s): Clinical disease activity at Week 32 as measured by the percentage of subjects with ASDAS inactive disease (ASDAS < 1.3) in the two treatment arms.;Timepoint(s) of evaluation of this end point: Week 32	—

Measure

Time frame

Main Objective: To compare a treat-to-target (T2T) intense treatment approach with a routine treatment approach (Standard of Care [SOC]) in reducing disease activity at week 32 in patients with axial spondyloarthritis (axSpA).;Secondary Objective: To compare a T2T intense treatment approach with SOC by assessing the following: improvement of quality of life, improvement of function, improvement of work productivity, reducing inflammation, reducing disease activity;Primary end point(s): Clinical disease activity at Week 32 as measured by the percentage of subjects with ASDAS inactive disease (ASDAS < 1.3) in the two treatment arms.;Timepoint(s) of evaluation of this end point: Week 32

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Secondary

Measure	Time frame
Secondary end point(s): Quality of life: EQ-5D Questionnaire, Work Productivity and Activity Impairment: WPAI-axSpA, Overall functioning: ASAS HI, Disease activity: BASDAI, Percentage of subjects achieving 50% improvement in BASDAI, Function: BASFI NRS score, Disease activity: ASDAS, Percentage of subjects in ASDAS inactive disease (ASDAS < 1.3), Percentage of subjects with low disease activity (ASDAS < 2.1), Percentage of subjects with moderate disease activity (ASDAS =1.3 to < 2.1), Percentage of subjects with high disease activity (ASDAS = 2.1 to < 3.5), Percentage of subjects with very high disease activity (ASDAS = 3.5), ASAS 20, ASAS 40, and ASAS Partial Remission, Active inflammation: MRI of the sacroiliac joints and the spine, Physician’s Global Assessment of Disease Activity, Patient’s Global Assessment of Disease Activity, Patient’s Global Assessment of Pain, Swollen Joint Count, Tender Joint Count, Change from baseline in MASES, Change from baseline in Dactylitis count, Anterior uveitis, C-reactive Protein, Erythrocyte sedimentation rate, ASDAS course over time, BASDAI course over time.;Timepoint(s) of evaluation of this end point: Weeks 32 and 52	—

Measure

Time frame

Secondary end point(s): Quality of life: EQ-5D Questionnaire, Work Productivity and Activity Impairment: WPAI-axSpA, Overall functioning: ASAS HI, Disease activity: BASDAI, Percentage of subjects achieving 50% improvement in BASDAI, Function: BASFI NRS score, Disease activity: ASDAS, Percentage of subjects in ASDAS inactive disease (ASDAS < 1.3), Percentage of subjects with low disease activity (ASDAS < 2.1), Percentage of subjects with moderate disease activity (ASDAS =1.3 to < 2.1), Percentage of subjects with high disease activity (ASDAS = 2.1 to < 3.5), Percentage of subjects with very high disease activity (ASDAS = 3.5), ASAS 20, ASAS 40, and ASAS Partial Remission, Active inflammation: MRI of the sacroiliac joints and the spine, Physician’s Global Assessment of Disease Activity, Patient’s Global Assessment of Disease Activity, Patient’s Global Assessment of Pain, Swollen Joint Count, Tender Joint Count, Change from baseline in MASES, Change from baseline in Dactylitis count, Anterior uveitis, C-reactive Protein, Erythrocyte sedimentation rate, ASDAS course over time, BASDAI course over time.;Timepoint(s) of evaluation of this end point: Weeks 32 and 52

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Countries

Germany

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com00441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026