[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

86-0592-13600932661

Email address

Gshi@xmu.edu.cn

Condition

Axial Spondyloarthritis

Treatment type

Interventional

Investigational product

To continue NSAIDs therapy

Phase

N/A

Sponsor

The First Affiliated Hospital of Xiamen University

ClinicalTrials.gov identifier

NCT03425812

Study number

20180101

Understanding clinical trials

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About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Capable of giving informed consent and complying with the examination program of the protocol;
  2. Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
  3. Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS<1.3;
  4. 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.
  5. 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;
  6. 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.
Exclusion criteria
  1. Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
  2. Participants who are intolerant of NSAIDs;
  3. Participants who are in active axSpA episodes;
  4. Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
  5. Participants who were in acute infection or acute attack of chronic infection during screening period;
  6. 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.
  7. 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);
  8. Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
  9. Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;
  10. Participants with severe, progressive, uncontrolled vital organ and systematic disorders, and other conditions that are considered inappropriate to participate in this trial;
  11. Participants with circumstances that may affect the compliance (e.g. prolonged travel or leave, planned relocation, mental illness, lack of motivation to participate, etc.).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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