Clinical trial NCT01359943: Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
Official title: A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
secukinumab
AIN457
inflammatory joints
American College of Rheumatology
ACR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 221
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: 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.


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.

Primary outcomes:
measure: Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieve ACR50 and ACR70
timeFrame: 12 weeks
measure: Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.
timeFrame: baseline, 12 Weeks
measure: Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)
timeFrame: baseline, 12 weeks
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Swollen 66-joint Count
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Tender 68-joint Count
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Participant's Global Assessment of Disease Activity
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Physician's Global Assessment of Disease Activity
timeFrame: baseline, 12 weeks
measure: Change From Baseline in hsCRP
timeFrame: baseline, 12 weeks
measure: Change From Baseline in ESR
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Vestavia
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Upland
country: United States
facility: Novartis Investigative Site
state: California
city: Bowling Green
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Tupelo
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sevlievo
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Valeggio Sul Mincio
country: Italy
facility: Novartis Investigative Site
state: (vr)
city: Arenzano
country: Italy
facility: Novartis Investigative Site
state: GE
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
state: Slovensko
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Partizánske
country: Slovakia
facility: Novartis Investigative Site
city: Piestany
country: Slovakia
facility: Novartis Investigative Site
city: Sabinov
country: Slovakia
facility: Novartis Investigative Site
city: Stara Lubovna
country: Slovakia
facility: Novartis Investigative Site
city: Topolcany
country: Slovakia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmceuticals
role: STUDY_DIRECTOR
References:
citation: Tlustochowicz W, Rahman P, Seriolo B, Krammer G, Porter B, Widmer A, Richards HB. Efficacy and Safety of Subcutaneous and Intravenous Loading Dose Regimens of Secukinumab in Patients with Active Rheumatoid Arthritis: Results from a Randomized Phase II Study. J Rheumatol. 2016 Mar;43(3):495-503. doi: 10.3899/jrheum.150117. Epub 2016 Feb 1.