Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study (ARISE)

May 6, 2026 updated by: Jian Zhu, Chinese PLA General Hospital

Effectiveness and Safety of Acemetacin in Patients With Active Axial Spondyloarthritis: A Prospective, Multicenter, Observational Real-World Study

The goal of this observational study is to evaluate the effectiveness and safety of acemetacin in adults (18-65 years) with active axial spondyloarthritis (axSpA) who meet the 2025 ASAS-SPARTAN revised classification criteria and have an ASDAS score greater than 2.1.

The main questions this study aims to answer are:

  • Does acemetacin reduce overall pain assessed by visual analog scale (VAS) after 4 weeks of treatment?
  • What proportion of patients achieve clinical remission (ASDAS ≤1.3) or low disease activity (1.3<ASDAS≤2.1) at week 4?
  • What medical problems (side effects) occur during acemetacin treatment, with particular attention to gastrointestinal and cardiovascular events?

Participants will:

  • Undergo screening assessments including blood tests, imaging of the sacroiliac joints (MRI, CT, X-ray), and physical examination within 7 days before starting treatment
  • Take acemetacin 90 mg by mouth once daily for 4 weeks
  • Complete a phone follow-up at week 2 and an in-clinic visit at week 4
  • Have pain scores, disease activity measures (ASDAS, BASDAI, BASFI, ASAS HI, BASMI), and laboratory tests (CRP, ESR) recorded at each visit
  • Be monitored for adverse events throughout the treatment period

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, observational real-world study to evaluate the effectiveness and safety of acemetacin in patients with active axial spondyloarthritis (axSpA).

Background Axial spondyloarthritis is a chronic inflammatory disease primarily affecting the axial skeleton, characterized by inflammatory back pain, morning stiffness, enthesitis, and peripheral arthritis, with possible extra-articular manifestations such as uveitis and psoriasis. The disease predominantly affects young males aged 20-30 years and can lead to persistent pain, progressive spinal immobility, and substantial disability if not adequately treated. The estimated prevalence of axSpA in mainland China is approximately 0.3%, affecting over 4 million individuals. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line therapy by major international and Chinese clinical practice guidelines. Acemetacin is a prodrug NSAID that is metabolized to indomethacin in vivo, with a potentially favorable gastrointestinal safety profile due to reduced direct mucosal irritation. However, prospective real-world evidence evaluating its effectiveness across different axSpA phenotypes - radiographic (r-axSpA) versus non-radiographic (nr-axSpA) - and disease durations remains limited.

Study Design This study enrolls 150 adults aged 18-65 years who fulfill the 2025 ASAS-SPARTAN revised axSpA classification criteria with an ASDAS score >2.1. Key exclusion criteria include hypersensitivity to acemetacin or other NSAIDs, active or recurrent gastrointestinal ulceration or bleeding, severe cardiac/renal/hepatic insufficiency, inflammatory bowel disease, and use of systemic glucocorticoids, intra-articular corticosteroid injections, or targeted therapies within 3 months before enrollment. Stable use of conventional synthetic DMARDs (e.g., sulfasalazine) initiated more than 3 months prior is permitted.

After a screening period of up to 7 days, eligible participants receive acemetacin 90 mg orally once daily for 4 weeks. A telephone follow-up is conducted at week 2, and an in-clinic visit at week 4. Early termination visits are scheduled within 3 days of the last dose for participants who discontinue prematurely.

Endpoints The primary endpoint is: the mean change from baseline in overall pain VAS score at week 4, and differences across predefined subgroups. Secondary endpoints include: (1) the proportion of patients achieving clinical remission (ASDAS ≤1.3) or low disease activity (1.3<ASDAS≤2.1) at week 4; (2) changes from baseline in pain VAS, BASDAI, BASFI, ASAS Health Index, and BASMI at weeks 2 and 4; and (3) changes from baseline in CRP and ESR at week 4. All secondary endpoints are also analyzed across subgroups. Safety is assessed by monitoring adverse events graded per CTCAE v5.0, with special attention to gastrointestinal and cardiovascular events.

Statistical Considerations Based on an assumed standard deviation of 2 for the change in VAS pain score, with a two-sided significance level of 0.05 and 80% power, a minimum of 136 participants are required. Accounting for potential attrition, the planned enrollment is 150 participants.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qianqian Zhao, M.M.
  • Phone Number: +86 010-55499314
  • Email: zqq20901@163.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects who fully understand the purpose and procedures of the trial and voluntarily sign the Informed Consent Form (ICF);
  • Subjects aged 18-65 years (inclusive), regardless of gender;
  • Meet the 2025 ASAS-SPARTAN Revised Classification Criteria for Axial Spondyloarthritis;
  • ASDAS score > 2.1.

Exclusion Criteria:

  • Subjects with known allergy to acemetacin, other NSAIDs, or any excipients;
  • Subjects with active gastrointestinal ulcer/bleeding, or a history of recurrent ulcer/bleeding;
  • Subjects with severe cardiac or renal dysfunction, or hepatic dysfunction;
  • Subjects with ulcerative colitis or Crohn's disease;
  • Subjects who received systemic glucocorticoids or intra-articular glucocorticoid injections within 3 months prior to the study start;
  • Subjects who received targeted therapy within 3 months prior to the study start;
  • Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acemetacin
After signing the Informed Consent Form (ICF), subjects entered the screening period and completed screening evaluations according to the visit schedule in the trial flow chart. The screening period lasted up to 7 days, and subjects who met all inclusion criteria and did not meet any exclusion criteria entered the treatment period. The study planned to enroll 150 subjects with axial spondyloarthritis, all of whom received acemetacin sustained-release capsules. All subjects were administered acemetacin: 1 capsule per dose, once daily, for 4 weeks.
Drug: Acemetacin
Acemetacin is a non-steroidal anti-inflammatory drug (NSAID) belonging to the indole derivative class and serves as a prodrug of indomethacin. After oral administration, it is hydrolyzed in vivo to indomethacin, exerting anti-inflammatory, analgesic, and antipyretic effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Changes in overall pain score
Time Frame: Baseline and Week 4
The mean change in overall pain score from baseline after 4 weeks of acemetacin treatment, and the differences in changes among different subgroups.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACM-axSpA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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