Compare the efficacy and assess 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 despite treatment with methotrexate

• Register: EUCTR
• Last refreshed on: 2 June 2014
• Main ID: EUCTR2010-024516-34-HU
• Date of registration: 29/06/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Compare the efficacy and assess 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 despite treatment with methotrexate
• Scientific title: A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate
• Date of first enrolment: 31/08/2011
• Target sample size: 215
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024516-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Bulgaria, Canada, Hungary, Italy, United States

Contacts

• Name: Public Information Desk
• Affiliation: Novartis Hungária Kft., Pharma

• Name: Public Information Desk
• Affiliation: Novartis Hungária Kft., Pharma

Key inclusion & exclusion criteria

Inclusion criteria:
- Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months before screening
- Must have been taking Methotrexate for at least 3 months before randomization and must currently be on a stable dose of Methotrexate 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 mm/1st hr

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion criteria:
- Rheumatoid arthritis 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 exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rheumatoid arthritis
MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Powder for solution for injection or infusion
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Response to treatment according to ACR 20 criteria

Main Objective: To demonstrate the superior efficacy of secukinumab administered during induction with an i.v. loading regimen or a s.c. loading dose regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate using the ACR 20 criteria.

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Objective: To compare the secukinumab regimens (i.v. and s.c.) to placebo and to each other for ACR 20, ACR 50 and ACR 70 response criteria, Health Assessment Questionnaire-Disability Index, Disease Activity Score (DAS) 28 response, ACR components, including markers of inflammation and to evaluate the overall safety and tolerability of secukinumab and investigate the development of immunogenicity against secukinumab.

Secondary Outcome(s)

Secondary end point(s): - ACR 20, ACR 50, and ACR 70 response criteria
- Change from baseline in HAQ-DI values
- DAS28-CRP, DAS28-ESR, and EULAR response criteria
- ACR component variables

Timepoint(s) of evaluation of this end point: For all secondary endpoints: every visit, Week 0 to 52

Secondary ID(s)

CAIN457F2206

Source(s) of Monetary Support

Novartis Pharma AG