Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

NCT01359943 | Completed Phase 2 Results

• 2 other identifiers: CAIN457F22062010-024516-34
• Study Type: interventional
• Target: 221
• Locations: 8 countries
• Sites: 39

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; RA; secukinumab; AIN457; inflammatory joints; American College of Rheumatology; ACR

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)

  A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).

  12 weeks

Secondary Outcomes (12)

• Percentage of Participants Who Achieve ACR50 and ACR70

  12 weeks

• Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.

  baseline, 12 Weeks

• Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)

  baseline, 12 weeks

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

  baseline, 12 weeks

• Percentage of Participants With European League Against Rheumatism (EULAR) Response

  baseline, 12 weeks

Study Arms (3)

secukinumab 10 mg/kg i.v. loading

EXPERIMENTAL

secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8

Biological: secukinumab (AIN457); Drug: placebo

secukinumab 150 mg s.c. loading

EXPERIMENTAL

secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8

Biological: secukinumab (AIN457); Drug: placebo

placebo

PLACEBO COMPARATOR

placebo at Weeks 0, 1, 2, 3, 4, 8 \& 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16

Biological: secukinumab (AIN457); Drug: placebo

Interventions

secukinumab (AIN457) BIOLOGICAL

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

placebo; secukinumab 10 mg/kg i.v. loading; secukinumab 150 mg s.c. loading

placebo DRUG

Matching placebo to AIN457 i.v. and to AIN457 s.c..

placebo; secukinumab 10 mg/kg i.v. loading; secukinumab 150 mg s.c. loading

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (39)

Novartis Investigative Site

Vestavia Hills, Alabama, 35216, United States

Location

Novartis Investigative Site

Peoria, Arizona, 85381, United States

Location

Novartis Investigative Site

Upland, California, 91786, United States

Location

Novartis Investigative Site

Bowling Green, Kentucky, 42101, United States

Location

Novartis Investigative Site

Tupelo, Mississippi, 38801, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

Location

Novartis Investigative Site

Jackson, Tennessee, 38305, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37205, United States

Location

Novartis Investigative Site

Pleven, Bulgaria, 5800, Bulgaria

Location

Novartis Investigative Site

Plovdiv, Bulgaria, 4000, Bulgaria

Location

Novartis Investigative Site

Plovdiv, Bulgaria, 4002, Bulgaria

Location

Novartis Investigative Site

Sevlievo, Bulgaria, 5400, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1505, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1606, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1612, Bulgaria

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Novartis Investigative Site

Sainte-Foy, Quebec, G1W 4R4, Canada

Location

Novartis Investigative Site

Szeged, Hungary, H-6725, Hungary

Location

Novartis Investigative Site

Budapest, 1023, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Valeggio sul Mincio, (vr), 37067, Italy

Location

Novartis Investigative Site

Arenzano, GE, 16011, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Torino, TO, 10128, Italy

Location

Novartis Investigative Site

Bialystok, 15-351, Poland

Location

Novartis Investigative Site

Poznan, 60-218, Poland

Location

Novartis Investigative Site

Warsaw, 02-341, Poland

Location

Novartis Investigative Site

Warsaw, 04-141, Poland

Location

Novartis Investigative Site

San Juan, 00909, Puerto Rico

Location

Novartis Investigative Site

Bardejov, Slovak Republic, 085 01, Slovakia

Location

Novartis Investigative Site

Lučenec, Slovakia, 98401, Slovakia

Location

Novartis Investigative Site

Partizánske, Slovakia, 95801, Slovakia

Location

Novartis Investigative Site

Piešťany, Slovakia, 92112, Slovakia

Location

Novartis Investigative Site

Sabinov, Slovakia, 08301, Slovakia

Location

Novartis Investigative Site

Stará Ľubovňa, Slovakia, 06401, Slovakia

Location

Novartis Investigative Site

Topoľčany, Slovakia, 95501, Slovakia

Location

Novartis Investigative Site

Trnava, Slovensko, 91701, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 26834211 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

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmceuticals

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 25, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 2, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-02

Locations

US (8); IT (6); HU (3); BU (7); PL (4); PR (1); CA (2); SL (8)