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

NCT00928512 | Completed Phase 2 Results

• 2 other identifiers: CAIN457F22012009-011000-34
• Study Type: interventional
• Target: 237
• Locations: 11 countries
• Sites: 58

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, RA, ACR, inflammatory joints

Outcome Measures

Primary Outcomes (1)

• Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks

  A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute phase rectant (C-reactive protein \[hsCRP\]/ESR).

  16cweeks

Secondary Outcomes (17)

• Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16

  Week 16

• Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16

  at Weeks2, 4, 8, 12, 16

• Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)

  Baseline, week 16

• Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)

  Baseline, week 16

• Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16

  Baseline, Week 16

Study Arms (5)

Secukinumab 25mg

EXPERIMENTAL

Secukinumab 25mg s.c. q4wk

Drug: Secukinmab

Secukinumab 75mg

EXPERIMENTAL

Secukinumab 75mg s.c. q4wk

Drug: Secukinmab

Secukinumab 150mg

EXPERIMENTAL

Secukinumab 150mg s. c. q4wk

Drug: Secukinmab

Secukinumab 300mg

EXPERIMENTAL

Secukinumab 300mg s.c. q4wk

Drug: Secukinmab

Secukinumab Placebo

PLACEBO COMPARATOR

Secukinumab Placebo s.c. q4wk

Drug: Placebo

Interventions

Secukinmab DRUG

Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.

Also known as: AIN457

Secukinumab 150mg; Secukinumab 25mg; Secukinumab 300mg; Secukinumab 75mg

Placebo DRUG

Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.

Secukinumab Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Mesa, Arizona, 85202, United States

Location

Novartis Investigative Site

Peoria, Arizona, 85381, United States

Location

Novartis Investigative Site

Little Rock, Arkansas, 72205, United States

Location

Novartis Investigative Site

Santa Monica, California, 90404, United States

Location

Novartis Investigative Site

Coeur d'Alene, Idaho, 83814, United States

Location

Novartis Investigative Site

Springfield, Illinois, 62704, United States

Location

Novartis Investigative Site

Kalamazoo, Michigan, 49048, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

Location

Novartis Investigative Site

Rochester, New York, 14609, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

Location

Novartis Investigative Site

Tulsa, Oklahoma, 74135-2920, United States

Location

Novartis Investigative Site

Greenville, South Carolina, 29601, United States

Location

Novartis Investigative Site

Jackson, Tennessee, 38305, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ostrava, Czech Republic, 72200, Czechia

Location

Novartis Investigative Site

Pardubice, Czech Republic, 53002, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

Location

Novartis Investigative Site

Prague, 128 50, Czechia

Location

Novartis Investigative Site

Bayreuth, 95445, Germany

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Novartis Investigative Site

Berlin, 14059, Germany

Location

Novartis Investigative Site

Hamburg, 22081, Germany

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Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Hildesheim, 31134, Germany

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Novartis Investigative Site

München, 80639, Germany

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Novartis Investigative Site

Budapest, 1062, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Gyula, 5700, Hungary

Location

Novartis Investigative Site

Iizuka, Fukuoka, 820-8505, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0044, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 658-0011, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 228-8522, Japan

Location

Novartis Investigative Site

Kurashiki, Okayama-ken, 710-8522, Japan

Location

Novartis Investigative Site

Kawagoe, Saitama, 350-1103, Japan

Location

Novartis Investigative Site

Bialystok, 15-337, Poland

Location

Novartis Investigative Site

Bialystok, 15-461, Poland

Location

Novartis Investigative Site

Lublin, 20-607, Poland

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Moscow, 117049, Russia

Location

Novartis Investigative Site

Moscow, 129327, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194104, Russia

Location

Novartis Investigative Site

Saint Petersburg, 195257, Russia

Location

Novartis Investigative Site

Tula, 300053, Russia

Location

Novartis Investigative Site

Tver', 170036, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Košice, Slovak Republic, 040 15, Slovakia

Location

Novartis Investigative Site

Piešťany, Slovak Republic, 921 12, Slovakia

Location

Novartis Investigative Site

Banská Bystrica, 975 17, Slovakia

Location

Novartis Investigative Site

Busan, Busan, 602-739, South Korea

Location

Novartis Investigative Site

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 137-701, South Korea

Location

Novartis Investigative Site

Seoul, 143-729, South Korea

Location

Novartis Investigative Site

Niaosong Township, Taiwan, 83301, Taiwan

Location

Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

Location

Novartis Investigative Site

Taichung, Taiwan, 40705, Taiwan

Location

Novartis Investigative Site

Taichung, Taiwan ROC, 40201, Taiwan

Location

Novartis Investigative Site

Changhua, 500, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 24429175 DERIVED

• 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.

  PMID: 22730366 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 30, 2015
• Results First Posted: July 30, 2015

Record last verified: 2015-10

Locations

HU (3); US (13); KR (4); BE (1); JP (6); SL (3); RU (9); DE (6); TW (6); CZ (4); PL (3)