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New treatment option for Axial Spondyloarthritis
Official title Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
ClinicalTrials.gov ID: NCT03425812
What this study is testing
What is To withdraw NSAIDs therapy?
To withdraw NSAIDs therapy is an investigational medicine, being studied as a potential treatment for axial spondyloarthritis.
Also referred to as Non-NSAIDs, Break-off (on-demand) NSAID therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
- Participants who are intolerant of NSAIDs;
- Participants who are in active axSpA episodes;
- Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
- 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...
See the full eligibility criteria
- 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...
- 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.
- Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
- Participants who are intolerant of NSAIDs;
- Participants who are in active axSpA episodes;
- Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
- 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...
- Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
- Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.