Clinical trial NCT03425812: Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
Official title: Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission：A Multicenter, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Axial Spondyloarthritis
Keywords: Axial Spondyloarthritis
Anti-Inflammatory Drugs
Flare
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Fujian Medical University
name: Peking University Shenzhen Hospital
name: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Quanzhou Orthopedic-traumatological Hospital of Fujian Traditional Chinese Medicine University
name: Fujian Medical University Union Hospital
First posted: 2018-02-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;

Eligibility criteria: Inclusion 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 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.

Exclusion Criteria:

* 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 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 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.).

Primary outcomes:
measure: Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease
timeFrame: From Week 0 (baseline) to Week24
Secondary outcomes:
measure: Change in Patient global assessment of disease activity
timeFrame: From Week 0 (baseline) to Week24
measure: Change in total Back Pain
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Short Form-36 Physical Component Summary (SF-36 PCS)
timeFrame: From Week 0 (baseline) to Week24
measure: Change in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Chest Expansion
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES)
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Number of swelling and tendons affected by enthesitis
timeFrame: From Week 0 (baseline) to Week24
measure: Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR)
timeFrame: From Week 0 (baseline) to Week24
measure: Observation of relapse time after withdrawal of NSAIDs in remission patients
timeFrame: From Week 0 (baseline) to Week24
measure: The difference of flare rate between different treatment groups
timeFrame: Week12 and Week24
measure: The difference of flare rate between in patients with different sacroiliac joint grades on X-ray among different groups.
timeFrame: Week12 and Week24
measure: The difference of osteophyte formation between different groups on Modified Stoke ankylosing spondylitis spine score (mSASSS).
timeFrame: Week0 and Week24
measure: Comparison of BASFI and BASMI scores between different groups
timeFrame: Week12 and Week24
measure: Differences in MRI scores among different groups by SPARCC SSS method.
timeFrame: weeks-16, week 0, week 12 and week 24
measure: The difference of flare rate in patients with different MRI scores of sacroiliac joint.
timeFrame: Week0 and Week24
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Shi Guixiu, PhD
role: STUDY_DIRECTOR
References:
citation: Zheng Q, Liu W, Huang Y, Gao Z, Wu Y, Wang X, Cai M, He Y, Chen S, Wang B, Liu L, Chen S, Huang H, Zheng L, Kang R, Zeng X, Chen J, Chen H, Chen J, Li Z, Shi G. Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission. Rheumatol Ther. 2021 Mar;8(1):411-424. doi: 10.1007/s40744-021-00279-y. Epub 2021 Feb 18.