Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhixiang Huang
• Treatments: Celecoxib; Etanercept; Sulfasalazine

Criteria

Inclusion Criteria:

1. Patients 18 to 45 years of age.

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:

1. Pregnancy/lactation.

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.