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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01358175
• Date of registration: 19/05/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis MEASURE 1
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
• Date of first enrolment: October 2011
• Target sample size: 371
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01358175
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, Bulgaria, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Russian Federation, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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-TNFa 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 TNFa

- Previous treatment with any cell-depleting therapies

- Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Placebo

Drug: Secukinumab (150 mg)

Drug: Secukinumab (75 mg)

Primary Outcome(s)

Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response [Time Frame: 16 weeks]

Secondary Outcome(s)

Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response [Time Frame: 16 weeks]

Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS [Time Frame: baseline, 16 weeks]

Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response [Time Frame: 16 weeks]

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI [Time Frame: Baseline and 16 weeks]

Change From Baseline in Serum hsCRP [Time Frame: Base line and Week 16]

Assessment of Responders for ASAS Partial Remission [Time Frame: 16 weeks]

Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL [Time Frame: baseline and 16 weeks]

Secondary ID(s)

2010-024529-18

CAIN457F2305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01358175