Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04077957
• Date of registration: 01/09/2019
• 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
• Scientific title: Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study
• Date of first enrolment: October 7, 2019
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04077957
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

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

• Name: Minkai Song

• Name: Minkai Song, MD.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Capability to understand and voluntarily give written informed consent that is signed
and dated, before any specific procedure of the protocol is performed.

- Patients 18 to 45 years of age.

- Proven AS according to the modified New York criteria.

- Acute phase of disease with ASDAS score =1.3.

- Ability to reconstitute the drug and self-inject it or have a person who can do so.

- Ability to store injectable test article at 2º to 8º C.

Exclusion Criteria:

- Patients with a history of active tuberculosis, hepatitis, gastrointestinal
hemorrhage, tumors, infectious diseases or combined with other rheumaimmune systemic
diseases or osteoarthritis diseases.

- Pregnancy/lactation.

- Receipt of any live (attenuated) vaccines within 4 weeks before the screening visit.

- 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.

- Participation in trials of other investigational medications within 30 days of
entering the study.

- Clinical examination showing significant abnormalities of clinical relevance.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spondyloarthritis

Ankylosing Spondylitis

Intervention(s)

Drug: Etanercept (50mg per week, for 2 weeks)

Drug: Hydroxychloroquine

Drug: Methotrexate

Drug: Sulfasalazine

Drug: Etanercept (50mg per week)

Drug: Etanercept (50mg per week, for 4 weeks)

Primary Outcome(s)

Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response [Time Frame: Week 12, 24, 36, 48]

Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response [Time Frame: Week 12, 24, 36, 48]

Secondary Outcome(s)

Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48]

Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48]

Mean Change From Baseline in SpondyloArthritis Research Consortium of Canada (SPARCC) Score for the Sacroiliac Joint [Time Frame: Baseline, Week 4, 12, 24, 48]

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score [Time Frame: Baseline, Week 12, 24, 36, 48]

Percentage of Participants with Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity From Baseline [Time Frame: Baseline, Week 12, 24, 36, 48]

Mean Change From Baseline in C-Reactive Protein (CRP) [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48]

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score [Time Frame: Baseline, Week 12, 24, 36, 48]

Mean Change From Baseline in Short Form-36 Health Survey (SF-36) Score [Time Frame: Baseline, Week 12, 24, 36, 48]

Mean Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Score [Time Frame: Baseline, Week 12, 24, 36, 48]

Secondary ID(s)

NFEC-2019-122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors