Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

Novartis

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: secukinumab (AIN457); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359943

2010-024516-34 (EudraCT Number)

CAIN457F2206

Details and patient eligibility

About

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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

221 participants in 3 patient groups, including a placebo group

secukinumab 10 mg/kg i.v. loading

Experimental group

Description:

secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8

Treatment:

Drug: placebo

Biological: secukinumab (AIN457)

secukinumab 150 mg s.c. loading

Experimental group

Description:

secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8

Treatment:

Drug: placebo

Biological: secukinumab (AIN457)

placebo

Placebo Comparator group

Description:

placebo at Weeks 0, 1, 2, 3, 4, 8 \& 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16

Treatment:

Drug: placebo

Biological: secukinumab (AIN457)