Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study

• Register: ChiCTR
• Last refreshed on: 9 September 2019
• Main ID: ChiCTR1900025749
• Date of registration: 2019-09-07
• Prospective Registration: Yes
• Primary sponsor: Nanfang Hospital of Southern Medical University
• Public title: Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study
• Scientific title: Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study
• Date of first enrolment: 2019-09-20
• Target sample size: Experimental:50;Experimental:50;Experimental:50;Positive Control:50;Positive Control:50;Positive Control:50;Positive Control:50;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=43043
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Minkai Song
• Affiliation: NanFang Hospital of Southern Medical University

• Name: Jun Xiao
• Affiliation: NanFang Hospital of Southern Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1) Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed;
2) Patients 18 to 50 years of age;
3) Proven AS according to the modified New York criteria;
4) Acute phase of disease with ASDAS score >=1.3.
Exclusion criteria: 1) Patients with a history of active tuberculosis, hepatitis, gastrointestinal hemorrhage, tumors, infectious diseases or combined with other rheumaimmune systemic diseases or osteoarthritis diseases;
2) Pregnancy/lactation;
3) Receipt of any live (attenuated) vaccines within 4 weeks before the screening visit;
4) Significant concurrent medical diseases including uncompensated congestive heart failure (NYHA III-IV), myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection;
5) Participation in trials of other investigational medications within 30 days of entering the study;
6) Clinical examination showing significant abnormalities of clinical relevance.

Age minimum: 18
Age maximum: 50
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Experimental:conventional synthetic Disease modifying anti-rheumatic drugs(csDMARDs);Experimental:Etanercept (Anbainuo 50mg per week, for 4 weeks);Experimental:Etanercept (Anbainuo 50mg per week, for 2 weeks);Positive Control:Etanercept (Anbainuo 50mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 50mg per 10 days, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per 2 weeks, for 12 weeks);

Primary Outcome(s)

Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response;Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response;

Secondary Outcome(s)

Mean Change From Baseline in C-Reactive Protein (CRP);Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR);Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score;Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score;Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score;Mean Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Score;Mean Change From Baseline in Short Form-36 Health Survey (SF-36) Score;Mean Change From Baseline in SpondyloArthritis Research Consortium of Canada (SPARCC) Score for the Sacroiliac Joint;

Secondary ID(s)

NCT04077957

Source(s) of Monetary Support

Latitudinal Project

Ethics review

Status: Approved
Approval date: 02/07/2019
Contact:

[e-mail]

Xingyuan Hu

[phone]

[e-mail]