Phase 4 Ankylosing Spondylitis Trial, Recruiting NCT05303285 Sponsor: Tongji Hospital Condition: Ankylosing Spondylitis
Back to Ankylosing Spondylitis

Phase 4 Ankylosing Spondylitis Trial, Recruiting

NCT05303285
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with ankylosing spondylitis (AS) and meet a specific set of recognised diagnostic standards for this condition.
  • Your disease is currently active, meaning your symptoms score 4 or higher (out of 10) on two standard AS activity questionnaires, measured at both your screening and baseline appointments.
  • You have tried at least two anti-inflammatory painkillers (such as ibuprofen or naproxen) at the highest recommended or tolerated doses for a total of at least 4 weeks without enough benefit, or you are unable to take these medications due to side effects or other medical reasons.
  • If you are already taking certain disease-modifying drugs (such as methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide), you must have been on a stable dose for at least 28 days before your baseline visit, within specified dose limits (confirm with trial site).
  • If you are already taking steroid tablets (such as prednisone at 10 mg per day or less), you must have been on a stable dose for at least 14 days before your baseline visit.
  • If you are already taking anti-inflammatory painkillers, tramadol, certain combination painkillers, or non-opioid pain relievers, you must have been on a stable dose for at least 14 days before your baseline visit.

Who may not be able to join:

  • You have previously taken any JAK inhibitor medication, such as tofacitinib, baricitinib, or filgotinib.
  • You have previously been treated with any biologic therapy that could affect your type of arthritis condition.
  • You have had a steroid injection into a joint, spine, or muscle within 28 days before your baseline visit (inhaled or skin-applied steroids are allowed).
  • You are currently taking certain other disease-modifying drugs, thalidomide, or apremilast within 28 days (or longer, depending on the medication) before your baseline visit.
  • You are using strong opioid painkillers or inhaled marijuana within 14 days before your baseline visit (some combination painkillers containing codeine or hydrocodone are allowed — confirm with trial site).
  • You have a history of another type of inflammatory joint disease other than ankylosing spondylitis (such as rheumatoid arthritis, lupus, or psoriatic arthritis), or any joint disease that began before the age of 17.
  • Your recent blood test results show that your liver function, kidney function, or blood cell counts fall outside the levels considered safe for this trial (confirm specific values with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: AIHUA DU, M.D, Tongji Hospital

Phone: 15671678920

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Tongji Hospital
Registry
ClinicalTrials.gov
Start date
14 June 2024
Est. completion
31 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov