Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis
NCT ID: NCT02638896
Last Updated: 2015-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-01-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose reduction arm
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.
etanercept (Half-Dose)
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 .
Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Dose maintenance arm
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.
etanercept (Full-Dose)
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.
Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Etanercept discontinuation arm
AS patients who achieved remission will take sulfasalazine (2g/d) till week24. Celecoxib will be the background therapy.
Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Interventions
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etanercept (Half-Dose)
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 .
etanercept (Full-Dose)
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.
Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Proven AS according to the modified New York criteria
3. 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.
4. Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception.
5. ASDAS score ≥2.1
6. Ability to reconstitute the drug and self-inject it or have a person who can do so.
7. Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
8. Ability to store injectable test article at 2º to 8º C.
Exclusion Criteria
2. Previously exposure to murine or chimeric monoclonal antibodies.
3. Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.
4. History of chronic or a recent serious infection.
5. History of tuberculosis within the last 3 years.
6. History of malignancy.
7. 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.
8. Presence or history of confirmed blood dyscrasias.
9. History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening.
10. Laboratory exclusions are: hemoglobin level \< 8.5 mg/dl white blood cell count \< 3.5×10e9/l, platelet count \< 125 ×10e9/l, creatinine level \> 175 mcmol/l, liver enzymes \> 1.5 times the upper limit of normal or alkaline phosphatase \> 2 times the upper limit of normal.
11. Participation in trials of other investigational medications within 30 days of entering the study.
12. Clinical examination showing significant abnormalities of clinical relevance.
13. Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids.
14. Hypersensitivity to any regent of study.
18 Years
45 Years
ALL
No
Sponsors
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Zhixiang Huang
OTHER_GOV
Responsible Party
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Zhixiang Huang
MD
Principal Investigators
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Tianwang Li, MD
Role: PRINCIPAL_INVESTIGATOR
Guangdong No.2 Provincial People's Hospital
Central Contacts
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Other Identifiers
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2015117183344589
Identifier Type: -
Identifier Source: org_study_id