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

Phase 1

• Conditions: Axial spondyloarthritis; MedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-005398-18-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-16
• Study Completion: 2017-12-21
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

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 < 5 years
4. Subjects must have a baseline disease activity as defined by having an ASDAS = 2.1 or a BASDAI = 4
5. Subjects must be either NSAID-naïve or had not been treated with the maximal recommended dose during the last 2 weeks prior to the Baseline Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified