16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE 1)

Novartis

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Secukinumab (75 mg); Drug: Placebo; Drug: Secukinumab (150 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358175

CAIN457F2305

2010-024529-18 (EudraCT Number)

Details and patient eligibility

About

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
• Patients should have been on NSAIDs with an inadequate response
• Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
• Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion criteria

• Chest X-ray with evidence of ongoing infectious or malignant process
• Patients with total ankylosis of the spine
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
• Previous treatment with any cell-depleting therapies
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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371 participants in 3 patient groups, including a placebo group

Secukinumab 10 mg/kg i.v. / 75 mg s.c.

Experimental group

Description:

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Treatment:

Drug: Secukinumab (75 mg)

Secukinumab 10 mg/kg i.v. / 150 mg s.c.

Experimental group

Description:

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Treatment:

Drug: Secukinumab (150 mg)

Placebo

Placebo Comparator group

Description:

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Treatment:

Drug: Placebo