Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01350804
• Date of registration: 09/05/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1) NURTURE 1
• Scientific title: A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)
• Date of first enrolment: September 2011
• Target sample size: 551
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01350804
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hungary, Italy, Mexico, Romania, Russian Federation, Slovakia, Spain, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or non-pregnant, non-lactating female patients

- Presence of RA classified by ACR 2010 revised criteria for at least 3 months before
screening

- At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >=
6 swollen joints out of 66

WITH at least 1 of the following at screening:

- Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR

- Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

- High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR

- Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour

- Patients must have been taking at least one anti-TNF-a agent given at an approved dose
for at least 3 months before randomization and have experienced an inadequate response
to treatment or have been intolerant to at least one administration of an anti-TNF-a
agent

- Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at
least 3 months before randomization and have to be on a stable dose at least 4 weeks
before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated
dose)

Exclusion Criteria:

- Chest x-ray with evidence of ongoing infectious or malignant process, obtained within
3 months prior to screening and evaluated by a qualified physician

- RA patients functional status class IV according to the ACR 1991 revised criteria

- Patients who have ever received biologic 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

Rheumatoid Arthritis

Intervention(s)

Biological: Abatacept

Biological: AIN457

Biological: Placebo

Primary Outcome(s)

Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20). [Time Frame: week 24]

Secondary Outcome(s)

Percentage of Participants Achieving ACR50 [Time Frame: week 24]

Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) [Time Frame: baseline, week 24]

Change From Baseline in HAQ-DI - Observed Data [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM) [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24]

Change From Baseline in hsCRP - Observed Data [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: baseline, week 24]

Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24]

Secondary ID(s)

2011-000102-21

CAIN457F2309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01350804