Phase 3
Completed N=551
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 α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
Source: ClinicalTrials.gov NCT01350804 ↗Enrolled (actual)
551
Serious AEs
10.4%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20). — 28.3; 30.7; 18.1; 42.8 Percentage of participants — p=0.0458
◆ Published Evidence
Highly cited
180citations · ~20 / year
Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study.
Summary
The core and extension studies assessed 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. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.
Linked Publications (2)
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Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study.
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Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20). |
28.3; 30.7; 18.1; 42.8 | 0.0458 sig |
| SECONDARY Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) |
-1.47; -1.47; -1.02; -2.07 | — |
| SECONDARY Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.30; -0.39; -0.26; -0.61 | — |
| SECONDARY Percentage of Participants Achieving ACR50 |
11.6; 16.8; 9.4; 27.5 | — |
| SECONDARY Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation |
21.0; 17.5; 7.2; 10.9; 24.6; 21.2 | — |
| SECONDARY Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data |
22.7; 18.6; 7.7; 11.5; 5.1; 5.7 | — |
| SECONDARY Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM) |
-0.22; -0.21; -0.08; -0.19; -0.22; -0.25 | — |
| SECONDARY Change From Baseline in HAQ-DI - Observed Data |
-0.225; -0.215; -0.101; -0.194; -0.119; -0.079 | — |
| SECONDARY Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM |
-0.89; -0.73; -0.22; -0.50; -0.96; -0.90 | — |
| SECONDARY Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data |
-0.886; -0.759; -0.211; -0.502; -0.147; -0.141 | — |
| SECONDARY Change From Baseline in hsCRP - Observed Data |
-10.91; -10.31; -0.69; -5.64; -0.33; -0.84 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data |
-7.5; -8.4; -5.7; -9.5; -8.4; -1.1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01350804) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.