Phase 3
Completed N=637
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
Source: ClinicalTrials.gov NCT01377012 ↗Enrolled (actual)
637
Serious AEs
9.9%
Results posted
Mar 2017
Primary outcomePrimary: Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24 — 35.2; 35.2; 19.6 Percentage of Participants — p=0.0004
◆ Published Evidence
Established
41citations · ~5 / year
Secukinumab in Active Rheumatoid Arthritis after Anti-TNFα Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 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. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Linked Publications (2)
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Secukinumab in Active Rheumatoid Arthritis after Anti-TNFα Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 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 Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24 |
35.2; 35.2; 19.6 | 0.0004 sig |
| PRIMARY Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70 |
— | — |
| SECONDARY Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.35; -0.35; -0.24 | — |
| SECONDARY Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score |
0.59; 0.83; 1.73 | — |
| SECONDARY Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52 |
2.4; 0.9; 1.4 | — |
| SECONDARY Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28) |
— | — |
| SECONDARY Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses |
— | — |
| SECONDARY Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission |
— | — |
| SECONDARY Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2 |
— | — |
| SECONDARY Extension Phase: Immunogenicity Against Secukinumab |
— | — |
Eligibility Criteria
Inclusion criteria
- Male or non-pregnant, non-lactating female patients
- Presence of RA classified by American College of Rheumatology (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 (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 mm/1st hr
- 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 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 Japan only: 6 to 25 mg/week)
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 including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01377012) 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.