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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Study design:   
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
Address: 
Telephone:
Email:
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)
Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) [Time Frame: baseline, week 24]
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 Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM [Time Frame: baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24]
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 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 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]
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]
Percentage of Participants Achieving ACR50 [Time Frame: week 24]
Secondary ID(s)
2011-000102-21
CAIN457F2309
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 23/05/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01350804
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