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

Overview

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;

Interventions

• Drug To withdraw NSAIDs therapy
  NSAIDs therapy will be withdrew after washout period.
• Drug To continue NSAIDs therapy
  NSAIDs therapy will be continued.

Primary outcome measures

• Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease [Time frame: From Week 0 (baseline) to Week24]

Secondary outcome measures (12)

• Change in Patient global assessment of disease activity [Time frame: From Week 0 (baseline) to Week24]
• Change in total Back Pain [Time frame: From Week 0 (baseline) to Week24]
• Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time frame: From Week 0 (baseline) to Week24]
• Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [Time frame: From Week 0 (baseline) to Week24]
• Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [Time frame: From Week 0 (baseline) to Week24]
• Change in Short Form-36 Physical Component Summary (SF-36 PCS) [Time frame: From Week 0 (baseline) to Week24]
• Change in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [Time frame: From Week 0 (baseline) to Week24]
• Change in Chest Expansion [Time frame: From Week 0 (baseline) to Week24]
• Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) [Time frame: From Week 0 (baseline) to Week24]
• Change in Number of swelling and tendons affected by enthesitis [Time frame: From Week 0 (baseline) to Week24]
• Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR) [Time frame: From Week 0 (baseline) to Week24]
• Observation of relapse time after withdrawal of NSAIDs in remission patients [Time frame: From Week 0 (baseline) to Week24]

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Xiamen University — Xiamen

Publications

• 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. PMID 33598865

Identifiers

NCT: NCT03425812 · 20180101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗