Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E)
Phase 3
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080222163
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 454
Inclusion Criteria
*Subjects must give a written informed consent before any assessment is performed.
*Subjects must have completed the 104-week treatment period in the core study.
*Subjects who are deemed by the investigator to benefit from continued secukinumab therapy.
Exclusion Criteria
*Use of other investigational drugs except for secukinumab during the core study.
*Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
*Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response by American College of Rheumatology response criteria [ Time Frame: Baseline and every 3 months for up to 3 years ]<br>Improvement in RA signs and symptoms by response criteria established by the American College of Rheumatology (ACR20, ACR50, and ACR70)
- Secondary Outcome Measures
Name Time Method Functional ability and activity restriction measure, HAQ-DI [ Time Frame: Baseline, and every 3 months for up to 3 years ] <br>HAQ-DI includes questions about upper extremities, lower extremities, and activities that involve both. There are 20 questions about difficulty of dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.<br>Proportion of patients achieving Major Clinical Response [ Time Frame: Baseline, and every 3 months for up to 3 years ]<br>Major Clinical Response is defined as maintaining an ACR70 response over a continuous six-month period<br>RA disease activity as measured by Disease Activity Score (DAS28) [ Time Frame: Baseline, and every 3 months for up to 3 years ] <br>Changes in DAS28 measured on the basis of 28 tender and swollen joints relative to baseline