Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents. (NURTURE 1)
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01350804
First received: May 9, 2011
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Secukinumab (75 mg) Drug: Secukinumab (150 mg) Drug: Placebo Drug: Abatacept |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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-TNFα Agents |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Abatacept
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo as add-on therapy in patients with active RA despite stable treatment with MTX or another DMARD [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measure: improvement (change) of the Health Assessment Questionnaire - Disability Index (HAQ-DI) from baseline on secukinumab 75 mg or 150 mg compared to placebo [ Time Frame: week 24 ] [ Designated as safety issue: No ]
- Proportion of patients achieving major clinical response (continuous six-month period of ACR70 response) on secukinumab 75 mg or 150 mg compared to placebo (as originally randomized) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Proportion of patients achieving ACR20 response on secukinumab 75 mg or 150 mg compared to abatacept [ Time Frame: week 24 ] [ Designated as safety issue: No ]
- Improvement (change) of the HAQ-DI from baseline on secukinumab 75 mg or 150 mg compared to abatacept [ Time Frame: week 24 ] [ Designated as safety issue: No ]
- Proportion of patients achieving major clinical response (continuous six-month period of ACR70 response) on secukinumab 75 mg or 150 mg compared to abatacept [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 548 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 | Drug: Secukinumab (75 mg) |
| Experimental: Group 2 | Drug: Secukinumab (150 mg) |
| Placebo Comparator: Group 3 | Drug: Placebo |
| Active Comparator: Group 4 | Drug: Abatacept |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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-α 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-α 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 TNFα
- Previous treatment with any cell-depleting therapies
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350804
Show 171 Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | +1(862)778-8300 |
Show 171 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Clinical Disclosure Office, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01350804 History of Changes |
| Other Study ID Numbers: | CAIN457F2309, 2011-000102-21 |
| Study First Received: | May 9, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Brazil: National Health Surveillance Agency Canada: Health Canada Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control France: Conseil National de l'Ordre des Médecins Germany: Paul-Ehrlich-Institut Hungary: National Institute of Pharmacy Italy: Ethics Committee Mexico: Federal Commission for Sanitary Risks Protection Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Slovak Republic: Ethics Committee Spain: Agencia Española de Medicamentos y Productos Sanitarios United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Rheumatoid Arthritis RA ACR inflammatory joints |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Abatacept Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013