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

NCT04077957 | Unknown Phase 4

• 1 other identifier: NFEC-2019-122
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates clinical responses and cost-effectiveness of using etanercept (ETN) and conventional synthetic Disease modifying anti-rheumatic drugs (csDMARDs) with treat-to-target strategy in ankylosing spondylitis patients. Half of participants will be used treat-to-target strategy with ETN and csDMARDs, while the others will be used conventional therapy scheme with ETN only.

Conditions

Ankylosing Spondylitis; Spondyloarthritis

Keywords

disease modifying anti-rheumatic drugs(DMARDs); etanercept; ankylosing spondylitis; spondyloarthritis; treat-to-target

Outcome Measures

Primary Outcomes (2)

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

  ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least \>= 20 percent improvement from baseline and an absolute change \>=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.

  Week 12, 24, 36, 48

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

  ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (\>=) 40 percent improvement from baseline and an absolute change \>=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.

  Week 12, 24, 36, 48

Secondary Outcomes (9)

• Mean Change From Baseline in C-Reactive Protein (CRP)

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

• Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

  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

  Baseline, Week 12, 24, 36, 48

• Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

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

  Baseline, Week 12, 24, 36, 48

Study Arms (2)

Group 1. Experimental

EXPERIMENTAL

Etanercept 50mg per week plus conventional synthetic DMARDs(csDMARDs, methotrexate 10mg per week, sulfasalazine 2.25g per day, hydroxychloroquine 0.2g per day) for 4 weeks when in high disease activity; etanercept 50mg per week plus csDMARDs for 2 weeks and continue with csDMARDs only for 2 weeks when in low disease activity; csDMARDs only for 4 weeks when in disease remission status.

Drug: Methotrexate; Drug: Sulfasalazine; Drug: Hydroxychloroquine; Drug: Etanercept (50mg per week, for 4 weeks); Drug: Etanercept (50mg per week, for 2 weeks)

Group 2. Positive Control

ACTIVE COMPARATOR

Etanercept 50mg per week for first 12 weeks; etanercept 50mg per ten days for second 12 weeks; etanercept 25mg per week for next 12 weeks; etanercept 25mg per two week for next 12 weeks.

Drug: Etanercept (50mg per week)

Interventions

Methotrexate DRUG

Methotrexate 10mg per week will be the background therapy in participants in Group 1. Experimental.

Group 1. Experimental

Sulfasalazine DRUG

Sulfasalazine 2.25g per day will be the background therapy in participants in Group 1. Experimental.

Group 1. Experimental

Hydroxychloroquine DRUG

Hydroxychloroquine 0.2g per day will be the background therapy in participants in Group 1. Experimental.

Group 1. Experimental

Etanercept (50mg per week, for 4 weeks) DRUG

Participants in Group 1. Experimental who satisfied the criteria for high disease activity (ASDAS≥2.1) at every follow-up point will receive etanercept (50mg per week, for 4 weeks) in the next 4 weeks.

Also known as: Anbainuo®

Group 1. Experimental

Etanercept (50mg per week, for 2 weeks) DRUG

Participants in Group 1. Experimental who satisfied the criteria for low disease activity (2.1\>ASDAS≥1.3) at every follow-up point will receive etanercept (50mg per week, for 4 weeks) in the next 2 weeks.

Also known as: Anbainuo®

Group 1. Experimental

Etanercept (50mg per week) DRUG

Participants in Group 2. Positive Control will receive etanercept (50mg per week, for 12 weeks) for 48 weeks.

Also known as: Anbainuo®

Group 2. Positive Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Interventions

Methotrexate; Sulfasalazine; Hydroxychloroquine; Etanercept; Anbainuo protein, human

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Chloroquine; Aminoquinolines; Quinolines; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Jun Xiao

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minkai Song

CONTACT

+8615626066091; smkzw@163.com

Tao Yan

CONTACT

+86-020-62787191; 704905989@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants will be randomly divided into 2 groups evenly. Participants in Group 1 will be treated with etanercept and conventional synthetic DMARDs based on treat-to-target strategy, while the others in Group 2 will be treated with conventional therapy scheme using etanercept only.

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: October 7, 2019
• Primary Completion: October 31, 2021
• Study Completion: July 2, 2022
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)