Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

NCT02638896 | Unknown Phase 4

• 1 other identifier: 2015117183344589
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; Etanercept; Sulfasalazine; Efficacy; Safety; dose; reduction

Outcome Measures

Primary Outcomes (1)

• Change in ASDAS from baseline to week48.

  ASDAS includes CRP (mg/L); Apart from the value of CRP, the four additional self-reported items (rated on 0-10 numerical rating scale \[NRS\]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are calculated as follows: ASDAS= (0.121×total back pain) + (0.110×subject global) + (0.073×peripheral pain/swelling) + (0.058×duration of morning stiffness) + (0.579×Ln(CRP+1)).

  Baseline, Week12, Week24, Week48

Secondary Outcomes (6)

• Change in ESR from baseline to week48.

  Baseline, Week12, Week24, Week48

• Change in CRP from baseline to week48.

  Baseline, Week12, Week24, Week48

• Change in BASFI from baseline to Week48.

  Baseline, Week12, Week24, Week48

• Change in BASMI from baseline to Week48.

  Baseline, Week12, Week24, Week48

• Change in SPARCC score for the sacroiliac joint from baseline to Week48.

  Baseline, Week12, Week24, Week48

Study Arms (3)

Dose reduction arm

EXPERIMENTAL

AS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy.

Drug: etanercept (Half-Dose); Drug: Sulfasalazine; Drug: Celecoxib

Dose maintenance arm

ACTIVE COMPARATOR

AS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy.

Drug: etanercept (Full-Dose); Drug: Sulfasalazine; Drug: Celecoxib

Etanercept discontinuation arm

OTHER

AS patients who achieved remission will take sulfasalazine (2g/d) till week24. Celecoxib will be the background therapy.

Drug: Sulfasalazine; Drug: Celecoxib

Interventions

etanercept (Half-Dose) DRUG

AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .

Also known as: Enbrel

Dose reduction arm

etanercept (Full-Dose) DRUG

AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.

Also known as: Enbrel

Dose maintenance arm

Sulfasalazine DRUG

AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.

Also known as: Sulazine

Dose maintenance arm; Dose reduction arm; Etanercept discontinuation arm

Celecoxib DRUG

Celecoxib (0.4g/d) will be the background therapy.

Also known as: Celebrex

Dose maintenance arm; Dose reduction arm; Etanercept discontinuation arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients 18 to 45 years of age.
• Proven AS according to the modified New York criteria
• Negative result of a pregnancy test in serum in screening visit and in urine in baseline visit, done in all women, except those surgically sterilized and those who have at least one year of menopause.
• Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception.
• ASDAS score ≥2.1
• Ability to reconstitute the drug and self-inject it or have a person who can do so.
• Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
• Ability to store injectable test article at 2º to 8º C.

You may not qualify if:

• Pregnancy/lactation.
• Previously exposure to murine or chimeric monoclonal antibodies.
• Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.
• History of chronic or a recent serious infection.
• History of tuberculosis within the last 3 years.
• History of malignancy.
• Significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection, central nervous system demyelinating events suggestive of multiple sclerosis.
• Presence or history of confirmed blood dyscrasias.
• History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening.
• Participation in trials of other investigational medications within 30 days of entering the study.
• Clinical examination showing significant abnormalities of clinical relevance.
• Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids.
• Hypersensitivity to any regent of study.

Sponsors & Collaborators

• Zhixiang Huang: lead

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept; Sulfasalazine; Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Benzenesulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tianwang Li, MD

  Guangdong No.2 Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiang Huang, MD

CONTACT

86-20-89169091; huang-zhix@163.com

Weiming Deng, MD

CONTACT

86-20-89169090; 15088097855@163.com

Study Design

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

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 28, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share