Clinical trial NCT00928512: Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Official title: A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, RA, ACR, inflammatory joints
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks
timeFrame: 16cweeks
Secondary outcomes:
measure: Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16
timeFrame: Week 16
measure: Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
timeFrame: at Weeks2, 4, 8, 12, 16
measure: Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)
timeFrame: Baseline, week 16
measure: Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)
timeFrame: Baseline, week 16
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16
timeFrame: Baseline, Week 16
measure: Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)
timeFrame: Baseline, week 16
measure: Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16
timeFrame: Baseline, week 16
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Coeur d'Alene
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Kalamazoo
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site
city: Pardubice
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 2
country: Czech Republic
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czech Republic
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Gyula
country: Hungary
facility: Novartis Investigative Site
city: Iizuka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kawagoe
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Anyang-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tula
country: Russian Federation
facility: Novartis Investigative Site
city: Tver
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Piestany
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Niaosong Township
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Genovese MC, Durez P, Richards HB, Supronik J, Dokoupilova E, Aelion JA, Lee SH, Codding CE, Kellner H, Ikawa T, Hugot S, Ligozio G, Mpofu S. One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. J Rheumatol. 2014 Mar;41(3):414-21. doi: 10.3899/jrheum.130637. Epub 2014 Jan 15.
citation: Genovese MC, Durez P, Richards HB, Supronik J, Dokoupilova E, Mazurov V, Aelion JA, Lee SH, Codding CE, Kellner H, Ikawa T, Hugot S, Mpofu S. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis. 2013 Jun;72(6):863-9. doi: 10.1136/annrheumdis-2012-201601. Epub 2012 Jun 23.