Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E)

A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222163

Enrollment

454

Registered

2013-08-01

Start date

2013-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : AIN457 INN of investigational material : Secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Response by American College of Rheumatology response criteria [ Time Frame: Baseline and every 3 months for up to 3 years ] Improvement in RA signs and symptoms by response criteria established by the American College of Rheumatology (ACR20, ACR50, and ACR70)	—

Secondary

Measure	Time frame
Functional ability and activity restriction measure, HAQ-DI [ Time Frame: Baseline, and every 3 months for up to 3 years ] 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. Proportion of patients achieving Major Clinical Response [ Time Frame: Baseline, and every 3 months for up to 3 years ] Major Clinical Response is defined as maintaining an ACR70 response over a continuous six-month period RA disease activity as measured by Disease Activity Score (DAS28) [ Time Frame: Baseline, and every 3 months for up to 3 years ] Changes in DAS28 measured on the basis of 28 tender and swollen joints relative to baseline	—

Measure

Time frame

Functional ability and activity restriction measure, HAQ-DI [ Time Frame: Baseline, and every 3 months for up to 3 years ] 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. Proportion of patients achieving Major Clinical Response [ Time Frame: Baseline, and every 3 months for up to 3 years ] Major Clinical Response is defined as maintaining an ACR70 response over a continuous six-month period RA disease activity as measured by Disease Activity Score (DAS28) [ Time Frame: Baseline, and every 3 months for up to 3 years ] Changes in DAS28 measured on the basis of 28 tender and swollen joints relative to baseline

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026