Extension in AS: Sustainability of Benefits, Safety and Tolerability (MEASURE 1 ext)

Novartis

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Other: Placebo (Pbo); Biological: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01863732

2013-001089-40 (EudraCT Number)

CAIN457F2305E1

Details and patient eligibility

About

This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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274 participants in 6 patient groups

Secukinumab (AIN457) 75mg Grp1

Experimental group

Description:

Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

Treatment:

Biological: Secukinumab

Other: Placebo (Pbo)

Secukinumab (AIN457) 75 to 150mg Grp1

Experimental group

Description:

Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

Treatment:

Biological: Secukinumab

Other: Placebo (Pbo)

Secukinumab (AIN457) 150mg Grp2

Experimental group

Description:

Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

Treatment:

Biological: Secukinumab

Other: Placebo (Pbo)

Pbo in Core then AIN457 75mg Grp1

Experimental group

Description:

Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W

Treatment:

Biological: Secukinumab

Other: Placebo (Pbo)

Pbo in Core then AIN457 75 to 150mg Grp1

Experimental group

Description:

Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

Treatment:

Biological: Secukinumab

Other: Placebo (Pbo)

Pbo in Core then AIN457 150mg Grp2

Experimental group

Description:

Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

Treatment:

Biological: Secukinumab

Other: Placebo (Pbo)