16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02008916
• Date of registration: 08/12/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients MEASURE 3
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis
• Date of first enrolment: January 14, 2014
• Target sample size: 226
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02008916
• 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, Czech Republic, Czechia, Germany, Greece, Mexico, Norway, Portugal, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria:
pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI,
previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any
biological immunomodulating agent excluding TNF antagonists, previous cell depleting
therapy.



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

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Drug: Placebo secukinumab

Drug: Secukinumab

Primary Outcome(s)

Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response [Time Frame: 16 weeks]

Secondary Outcome(s)

Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) [Time Frame: Week 8 and Week 12]

Prefilled Syringe Patient Satisfaction Assessment [Time Frame: Baseline, weeks 8, 12 and 16]

ASAS 5/6 Response [Time Frame: 16 weeks]

Pre-filled Syringe Possible Hazard [Time Frame: Week 8 and Week 12]

Serum hsCRP [Time Frame: Baseline and 16 weeks]

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

ASAS 40 Response [Time Frame: 16 weeks]

ASAS Partial Remission [Time Frame: 16 weeks]

Secondary ID(s)

2013-001090-24

CAIN457F2314

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02008916