16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE2)

Novartis

Status and phase: Completed; Phase 3

Conditions: Anklyosing Spondylitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649375

CAIN457F2310

2012-000046-35 (EudraCT Number)

Details and patient eligibility

About

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant, non-lactating female patients
• 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 were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
• Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion criteria

• Chest X-ray (or MRI) 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 3 patient groups, including a placebo group

Secukinumab 75 mg

Experimental group

Description:

Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.

Treatment:

Drug: Secukinumab (75 mg)

Secukinumab 150 mg

Experimental group

Description:

Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks

Treatment:

Drug: Secukinumab (150 mg)

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks

Treatment:

Drug: Placebo