Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2016
• Main ID: NCT02638896
• Date of registration: 20/12/2015
• Prospective Registration: Yes
• Primary sponsor: Zhixiang Huang
• Public title: Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis
• Scientific title: Efficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing Spondylitis
• Date of first enrolment: January 2016
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02638896
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Contacts

• Name: Tianwang Li, MD
• Affiliation: Guangdong No.2 Provincial People's Hospital

• Name: Zhixiang Huang, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Celecoxib

Drug: etanercept (Full-Dose)

Drug: etanercept (Half-Dose)

Drug: Sulfasalazine

Primary Outcome(s)

Change in ASDAS from baseline to week48. [Time Frame: Baseline, Week12, Week24, Week48]

Secondary Outcome(s)

Change in BASMI from baseline to Week48. [Time Frame: Baseline, Week12, Week24, Week48]

Change in CRP from baseline to week48. [Time Frame: Baseline, Week12, Week24, Week48]

Change in ESR from baseline to week48. [Time Frame: Baseline, Week12, Week24, Week48]

Change in BASFI from baseline to Week48. [Time Frame: Baseline, Week12, Week24, Week48]

Change in SPARCC score for the sacroiliac joint from baseline to Week48. [Time Frame: Baseline, Week12, Week24, Week48]

Percentage of participants with serious adverse events (SAEs) or adverse events (AEs) by co-morbidity from baseline to Week48. [Time Frame: Baseline, Week12, Week24, Week48]

Secondary ID(s)

2015117183344589

Source(s) of Monetary Support

Please refer to primary and secondary sponsors