A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension
1 other identifier
interventional
100
5 countries
36
Brief Summary
This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Aug 2011
Typical duration for phase_2 rheumatoid-arthritis
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 12, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 2, 2015
CompletedAugust 10, 2015
August 1, 2015
2.5 years
August 12, 2011
February 12, 2015
August 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group
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
Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04
The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) = 0.36\*ln(CRP+1) + 0.014\*GH = 0.96. A DAS28-CRP score \> 5.1 implies active disease, \<3.2 implies controlled disease and \<2.6 implied remission. A negative change from baseline indicates improvement.
baseline, 12 weeks
Secondary Outcomes (2)
Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group
12 weeks
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
baseline, 12 weeks
Study Arms (2)
Secukinumab
EXPERIMENTAL10 mg/kg intravenous (I.V.)
Placebo
PLACEBO COMPARATORPlacebo I.V.
Interventions
In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.
Eligibility Criteria
You may qualify if:
- Diagnosis of rheumatoid arthritis
- Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
- Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment
- Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints and hsCRP \>10mg/L
You may not qualify if:
- Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria)
- Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
- Use of high potency opioid analgesics
- Pregnant or nursing (lactating) women
- Use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Novartis Investigative Site
Phoenix, Arizona, 85023, United States
Novartis Investigative Site
Tuscon, Arizona, 85724, United States
Novartis Investigative Site
Anahiem, California, 92804, United States
Novartis Investigative Site
Clearwater, Florida, 33756, United States
Novartis Investigative Site
Coral Gables, Florida, 33134, United States
Novartis Investigative Site
Fleming Island, Florida, 32003, United States
Novartis Investigative Site
Miami, Florida, 33143, United States
Novartis Investigative Site
Pinellas Park, Florida, 33781, United States
Novartis Investigative Site
Venice, Florida, 34292, United States
Novartis Investigative Site
Marietta, Georgia, 30060, United States
Novartis Investigative Site
South Bend, Indiana, 46601, United States
Novartis Investigative Site
Springfield, Missouri, 65807, United States
Novartis Investigative Site
Albuquerque, New Mexico, 87102, United States
Novartis Investigative Site
Statesville, North Carolina, 28625, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Novartis Investigative Site
San Antonio, Texas, 78217, United States
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Kortrijk, 8500, Belgium
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Berlin, 14059, Germany
Novartis Investigative Site
Frankfurt am Main, 60528, Germany
Novartis Investigative Site
Hamburg, GmbH 22769, Germany
Novartis Investigative Site
Herne, 44649, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Magdeburg, 39120, Germany
Novartis Investigative Site
München, 80336, Germany
Novartis Investigative Site
Smolensk, Russia, 214019, Russia
Novartis Investigative Site
Moscow, 117049, Russia
Novartis Investigative Site
Nizhny Novgorod, 603018, Russia
Novartis Investigative Site
Petrozavodsk, 185019, Russia
Novartis Investigative Site
Saint Petersburg, 194104, Russia
Novartis Investigative Site
Tver', 170036, Russia
Novartis Investigative Site
Yaroslavl, 150030, Russia
Novartis Investigative Site
Yaroslavl, 150062, Russia
Novartis Investigative Site
Manchester, Manchester, M41 5SL, United Kingdom
Novartis Investigative Site
Belfast, BT2 7BA, United Kingdom
Related Publications (1)
Burmester GR, Durez P, Shestakova G, Genovese MC, Schulze-Koops H, Li Y, Wang YA, Lewitzky S, Koroleva I, Berneis AA, Lee DM, Hueber W. Association of HLA-DRB1 alleles with clinical responses to the anti-interleukin-17A monoclonal antibody secukinumab in active rheumatoid arthritis. Rheumatology (Oxford). 2016 Jan;55(1):49-55. doi: 10.1093/rheumatology/kev258. Epub 2015 Aug 12.
PMID: 26268815DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
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, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2011
First Posted
August 31, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
August 10, 2015
Results First Posted
March 2, 2015
Record last verified: 2015-08