Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study

NCT02489760 | Unknown Phase 4

• 1 other identifier: CS08019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.

Conditions

Ankylosing Spondylitis

Keywords

Etanercept; Adalimumab; Ankylosing Spondylitis; Switch Study

Outcome Measures

Primary Outcomes (1)

• Bath AS disease activity index (BASDAI)

  The score of BASDAI on weeks 8

  weeks 8

Study Arms (2)

Adalimumab switch to Etanercept

EXPERIMENTAL

At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.

Biological: Adalimumab; Biological: Etanercept

Etanercept switch to Adalimumab

EXPERIMENTAL

At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.

Biological: Adalimumab; Biological: Etanercept

Interventions

Adalimumab BIOLOGICAL

The treatment arm will receive adalimumab 40 mg subcutaneously biweekly

Also known as: Humira

Adalimumab switch to Etanercept; Etanercept switch to Adalimumab

Etanercept BIOLOGICAL

The control arm will continue etanercept 25 mg subcutaneously twice a week

Also known as: Enbrel

Adalimumab switch to Etanercept; Etanercept switch to Adalimumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
• Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
• Stable glucocorticoid for 4 weeks.
• Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
• Stable anti-TNF biologics for 4 weeks.
• Written informed consent.

You may not qualify if:

• Serum creatinine ≥3.0 mg/dl.
• GPT≥5 times the laboratory's upper limit of normal.
• Pregnant or breast-feeding women.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Related Publications (1)

• Wei JC, Tsou HK, Leong PY, Chen CY, Huang JX. Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial. Front Med (Lausanne). 2020 Oct 30;7:566160. doi: 10.3389/fmed.2020.566160. eCollection 2020.

  PMID: 33195311 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab; Etanercept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Wei C- C, M.D.

  Chung Shan Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Etanercept versus Adalimumab in the Treatment of Patients with Ankylosing Spondylitis. A Switch Study.

Study Record Dates

• First Submitted: June 27, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

TW (1)