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NCT03425812Recruiting

Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission

Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission:A Multicenter, Randomized, Controlled Study

Source: ClinicalTrials.gov · Last updated 18 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;

Status (registry)
Recruiting
Study type
Interventional
Enrollment
140 (estimated)
First submitted
19 Jan 2018
Start date
15 Feb 2018
Primary completion date
20 Dec 2025
Lead sponsor
The First Affiliated Hospital of Xiamen University
NCT number
NCT03425812

What you commit to

  • Study type: Interventional
  • Planned participants: 140
  • From 15 Feb 2018 to the primary completion date, 20 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
  • Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
  • Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;

Other illness

  • Participants who were in acute infection or acute attack of chronic infection during screening period;
  • At the time of screening, participants who were in the acute stage of acute infection or chronic infection, and if the acute infection had improved, they could be re-screened.
  • Participants who suffer from invasive fungal infections (e.g. histoplasma, coccidiosis's, candida, aspergillus, blastomyces, pneumocystis, etc.) within the first 6 months of screening; Or opportunistic bacterial infections (e.g. bacterial, viral or other infections, including Legionella and Listeria);
  • Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
  • Participants with severe, progressive, uncontrolled vital organ and systematic disorders, and other conditions that are considered inappropriate to participate in this trial;
  • Participants with circumstances that may affect the compliance (e.g. prolonged travel or leave, planned relocation, mental illness, lack of motivation to participate, etc.).

Other

  • Participants who are intolerant of NSAIDs;
  • Participants who are in active axSpA episodes;

Who the study is looking for

  • Capable of giving informed consent and complying with the examination program of the protocol;
  • Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
  • Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS\<1.3;
  • Participants must fulfill the criteria of remission of aSpA defined as ASDAS\<1.3,then continuous to evaluate every four weeks for three times and ASDAS\<1.3 each time.
  • Laboratory results must fulfill following requirements: Hb≥85g/L;3.5×109/L≤WBC Count ≤10×109/L;Platelet count ≥ Normal lower limit; Liver function (ALT、TBIL) ≤Twofold of normal upper limit; Renal function (SCr) ≤Normal upper limit;
  • The pregnancy test must be negative for women of childbearing age; Efficient contraception must be taken for both male and female participants during the trial period and within three months after the end of the trial.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated hospital of Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.