Phase 3
Completed N=457
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Source: ClinicalTrials.gov NCT01892436 ↗Enrolled (actual)
457
Serious AEs
14.6%
Results posted
Jun 2019
Primary outcomePrimary: Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 — 71.3; 73.9; 73.2; 73.6 percentage of participants
◆ Published Evidence
Established
70citations · ~9 / year
Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial.
Summary
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
Linked Publications
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Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 |
71.3; 73.9; 73.2; 73.6; 69.7; 72.9 | — |
| PRIMARY Proportion of Subjects Who Reached ACR50 |
43.4; 51.0; 49.3; 47.2; 43.7; 52.9 | — |
| PRIMARY Proportion of Subjects Who Reached ACR70 |
23.8; 30.1; 28.2; 29.2; 24.6; 31.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.4537; -0.4592; -0.5642; -0.4115; -0.4171; -0.4619 | — |
| SECONDARY Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) |
53.1; 52.3; 63.9; 50.0; 52.8; 51.9 | — |
| SECONDARY Change From Baseline in Disease Activity Score-CRP (DAS28) |
-2.044; -1.904; -2.282; -1.853; -2.013; -1.962 | — |
| SECONDARY Percentage of Subjects Achieving Low Disease Activity |
70.3; 64.7; 70.4; 63.9; 69.5; 69.9 | — |
| SECONDARY Percentage of Subjects Achieving Disease Remission (DAS28<2.6) |
52.4; 50.3; 47.9; 45.8; 54.6; 49.4 | — |
Eligibility Criteria
Inclusion criteria
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
- Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
- Subjects must be deemed by the investigator to benefit from continued secukinumab therapy
Exclusion criteria
- Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
- Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01892436) 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.