Phase 2
Completed N=221
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
Source: ClinicalTrials.gov NCT01359943 ↗Enrolled (actual)
221
Serious AEs
4.2%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20) — 53.4; 44.9; 40.9 Percentage of participants
Summary
The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20) |
53.4; 44.9; 40.9 | — |
| SECONDARY Percentage of Participants Who Achieve ACR50 and ACR70 |
20.5; 18.0; 11.4; 8.0; 5.6; 0.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score. |
-0.35; -0.28; -0.17 | — |
| SECONDARY Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP) |
-1.67; -1.65; -1.21 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR) |
-1.98; -1.80; -1.46 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response |
28.4; 27.0; 13.6; 46.6; 44.9; 52.3 | — |
| SECONDARY Change From Baseline in Swollen 66-joint Count |
-9.49; -9.81; -7.88 | — |
| SECONDARY Change From Baseline in Tender 68-joint Count |
-10.31; -11.99; -9.50 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain |
-14.41; -12.60; -6.66 | — |
| SECONDARY Change From Baseline in Participant's Global Assessment of Disease Activity |
-18.58; -15.29; -9.93 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity |
-27.05; -29.01; 18.88 | — |
| SECONDARY Change From Baseline in hsCRP |
-6.00; -5.72; -1.69 | — |
| SECONDARY Change From Baseline in ESR |
-16.68; -12.43; -10.53 | — |
Eligibility Criteria
Inclusion criteria
- presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
- must have been taking MTX for at least 3 months before randomization and must currently be on a stable dose of MTX for at least 4 weeks before randomization.
- At Baseline: Disease activity criteria defined by >6 tender joints out of 68 and >6 swollen joints out of 66 and with at least 1 of the following at screening: Anti-CCP antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: hsCRP ≥ 10 mg/L OR ESR ≥ 28
Exclusion criteria
- RA patients functional status class IV according to the ACR 1991 revised criteria
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
- Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
- Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01359943). 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.