Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT03622658
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤ 75 years of age.
* Diagnosis of axSpA by an appropriately qualified physician and classified using ASAS criteria ≥ 3 months prior to Baseline.
* Bath Ankylosing Spondylitis Disease Activity Index score ≥ 4 and spinal pain score ≥ 40, at screening and Baseline.
* MRI evidence of active axSpA ≤ 6 (ideally ≤ 3) months prior to randomisation using ASAS criteria.
* Stable NSAID use prior to study entry.
* Stable use of MTX, sulfasalazine or leflunomide prior to study entry.
* Stable oral corticosteroid dose prior to study entry.
* Capable of giving signed informed consent.
* Inadequately responded to or experienced intolerance to previous treatment with an anti-TNF agent (some subjects).
Exclusion Criteria:
* Current diagnosis of axSpA with a BASDAI \> 4 but no evidence of inflammation on MRI.
* Discontinued biologic therapy \< 8 weeks prior to Baseline.
* Previous or current use of oral corticosteroid as defined in protocol.
* Received intra-articular or i.v. corticosteroids prior to or during Screening.
* Received anti-IL-17A or anti-IL-12/23 therapy.
* Received cyclosporine, tacrolimus or mycophenolate mofetil prior to Baseline.
* Previously received stem cell transplantation.
* Infection(s) requiring treatment with i.v. anti-infectives or oral anti-infectives prior to Baseline.
* Abnormal screening laboratory and other analyses.
* Receipt of any live vaccine within 2 weeks prior to randomisation, or will require live vaccination during study participation.
* Evidence of current or prior dysplasia or history of malignancy.
* Has had any uncontrolled and/or clinically significant illness, hospitalisation, or any surgical procedure requiring general anaesthesia prior to Screening, or any planned surgical procedure within 6 months after randomisation.
* Known current or previous interstitial lung disease.
* Positive pregnancy test at Screening (serum) or Baseline (urine).
* Female subjects who are breastfeeding or considering becoming pregnant during the study.
* Considered by the Investigator to be an unsuitable candidate for the study.
* Received any investigational agent or procedure within 30 days or 5 half-lives prior to Baseline.
* Related to or a dependent of the site staff, or a member of the site staff.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03622658
Study Brief:
Protocol Section:
NCT03622658