A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis
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|ClinicalTrials.gov Identifier: NCT02685904|
Recruitment Status : Terminated (Sponsor's decision)
First Posted : February 19, 2016
Last Update Posted : March 12, 2019
This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The study period for each patient will be 27 weeks, during which the patient will undergo screening for up to 21 days, and followed by treatment of 24 weeks and follow up period of 2 weeks. Each patient will be required to make a total of 9 visits.
After re-confirming the eligibility of patients at Visit 2, eligible patients will be randomly assigned to either treatment group or control group in a 2:1 ratio. In addition, patients in the treatment group will receive ENIA11 25 mg twice weekly by subcutaneous injection while patients in the control group will receive placebo solution twice weekly by subcutaneous injection from Day 0 to week 12 and then switch to active drug from week 12 to week 24 and follow up period of 2 weeks.
The efficacy analysis, including ASAS response measures, ASAS5/6, ASDAS, BASDAS, BASFI, BASMI and individual measures of disease activity, such as numbers of swollen and tender joints, ESR and CRP, will be evaluated at each visit from Visit 2 (baseline) to Visit 9. Safety will be evaluated according to the frequency of adverse events, vital signs, physical examination, laboratory abnormalities, and ENIA11 antibody formation.
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Biological: ENIA11 Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis|
|Actual Study Start Date :||September 6, 2016|
|Actual Primary Completion Date :||January 28, 2018|
|Actual Study Completion Date :||December 31, 2018|
25 mg of ENIA11 subcutaneously administered twice weekly
Placebo Comparator: Placebo
25 mg of Placebo subcutaneously administered twice weekly
- ASAS 20 responder at Week 12 [ Time Frame: Week 12 ]The proportion of patient achieving ASAS 20 will be calculated for the treatment group (RT) and the control group (RC)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685904
|Kaohsiung Medical University Chung-Ho Memorial Hospital|
|Chung Shan Medical University Hospital|
|Far Eastern Memorial Hospital|
|Taipei City Hospital|
|Taipei Veterans General Hospital|
|Chang Gung Memorial Hospital|
|Taoyuan, Taiwan, 333|