NCT03425812

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2018Dec 2028

First Submitted

Initial submission to the registry

January 19, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2028

Expected
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

7.8 years

First QC Date

January 19, 2018

Last Update Submit

April 11, 2022

Conditions

Axial Spondyloarthritis

Keywords

Axial SpondyloarthritisAnti-Inflammatory DrugsFlare

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease

    ASDAS active disease is defined as ΔASDAS-CRP≥0.9. The ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation.

    From Week 0 (baseline) to Week24

Secondary Outcomes (18)

  • Change in Patient global assessment of disease activity

    From Week 0 (baseline) to Week24

  • Change in total Back Pain

    From Week 0 (baseline) to Week24

  • Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    From Week 0 (baseline) to Week24

  • Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

    From Week 0 (baseline) to Week24

  • Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

    From Week 0 (baseline) to Week24

  • +13 more secondary outcomes

Study Arms (2)

Non- NSAIDS group

EXPERIMENTAL

To withdraw NSAIDS therapy

Drug: To withdraw NSAIDs therapy

NSAIDS group

ACTIVE COMPARATOR

To continue NSAIDS therapy

Drug: To continue NSAIDs therapy

Interventions

To withdraw NSAIDs therapyDRUG

NSAIDs therapy will be withdrew after washout period.

Also known as: Non-NSAIDs, Break-off (on-demand) NSAID therapy, Break-off NSAID use (on-demand) group
Non- NSAIDS group
To continue NSAIDs therapyDRUG

NSAIDs therapy will be continued.

Also known as: NSAIDs, Regular (continuous) NSAID therapy, Regular (continuous) group
NSAIDS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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, 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Related Publications (1)

  • 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: 33598865DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Anti-Inflammatory Agents, Non-SteroidalPopulation Groups

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsDemographyPopulation Characteristics

Study Officials

  • Shi Guixiu, PhD

    The First Affiliated Hospital of Xiamen University

    STUDY DIRECTOR

Central Study Contacts

Shi Guixiu, PhD

CONTACT

86-0592-13600932661Gshi@xmu.edu.cn

Zheng Qing, PhD

CONTACT

86-0591-18650383162drmichaelzheng@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 8, 2018

Study Start

February 15, 2018

Primary Completion

December 20, 2025

Study Completion (Estimated)

December 20, 2028

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations

CN(1)