Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Novartis

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Secukinmab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928512

CAIN457F2201

2009-011000-34 (EudraCT Number)

Details and patient eligibility

About

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks
• At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr

Exclusion criteria

• RA patients functional status class IV classified according to the ACR 1991 revised criteria
• Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
• Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare 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: Triple Blind

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237 participants in 5 patient groups, including a placebo group

Secukinumab 25mg

Experimental group

Description:

Secukinumab 25mg s.c. q4wk

Treatment:

Drug: Secukinmab

Secukinumab 75mg

Experimental group

Description:

Secukinumab 75mg s.c. q4wk

Treatment:

Drug: Secukinmab

Secukinumab 150mg

Experimental group

Description:

Secukinumab 150mg s. c. q4wk

Treatment:

Drug: Secukinmab

Secukinumab 300mg

Experimental group

Description:

Secukinumab 300mg s.c. q4wk

Treatment:

Drug: Secukinmab

Secukinumab Placebo

Placebo Comparator group

Description:

Secukinumab Placebo s.c. q4wk

Treatment:

Drug: Placebo