Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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26 February 2018 |
Main ID: |
EUCTR2012-003536-23-IT |
Date of registration:
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05/02/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
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Scientific title:
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A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN |
Date of first enrolment:
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29/03/2013 |
Target sample size:
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200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003536-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Belgium
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Brazil
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Colombia
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Czech Republic
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Estonia
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Finland
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Germany
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Hungary
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Israel
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Italy
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Mexico
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Netherlands
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Norway
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Poland
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Romania
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Russian Federation
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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CONTACT POINT
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Address:
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Viale Bodio, 37/b
20158
MILANO
Italy |
Telephone:
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+39800226343 |
Email:
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informazioni.medicoscientifiche@sanofi.com |
Affiliation:
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sanofi-aventis SpA |
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Name:
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CONTACT POINT
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Address:
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Viale Bodio, 37/b
20158
MILANO
Italy |
Telephone:
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+39800226343 |
Email:
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informazioni.medicoscientifiche@sanofi.com |
Affiliation:
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sanofi-aventis SpA |
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Key inclusion & exclusion criteria
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Inclusion criteria: Diagnosis of RA, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with = 3 months disease duration.
ACR Class I-III functional status, based on the 1991 revised criteria.
Moderate-to-severely active RA.
Anti-TNF therapy failures, defined as patients with an inadequate clinical response defined by the investigator, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation. TNF-blockers may include, but are not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab pegol.
Continuous treatment with one or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) for at least 12 consecutive weeks and on a stable dose(s) for at least 6 consecutive weeks prior to randomization:
- Methotrexate – 10 to 25 mg/wk orally or intra muscular (or per local labeling requirements if the dose range differs)
- Leflunomide – 10 to 20 mg orally daily
- Sulfasalazine (SSZ) – 1000 to 3000 mg orally daily
- Hydroxychloroquine (HCQ) – 200 to 400 mg orally daily
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria: Patients <18 years of age.
Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.
Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to screening.
Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty’s syndrome.
Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening Visit, whichever is longer.
Patients with active tuberculosis or latent tuberculosis infection.
Prior or current history of interstitial lung disease.
Prior treatment with anti-IL-6 or anti-IL-6R antagonist therapies, including but not limited to tocilizumab or sarilumab.
Treatment with anti-TNF agents, as follows:
• Etanercept: within 28 days prior to randomization
• Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization.
Treatment with RA-directed biologic agents with non- TNF-a antagonist mechanisms without adequate washout as follows:
• Anakinra: within 28 days prior to randomization
• Abatacept: within 42 days prior to randomization
• Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count are normalized, or whichever is longer.
Prior treatment with a janus kinase (JAK) inhibitor (eg, tofacitinib).
Patients with a history of invasive opportunistic infection.
Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit.
Prior or current history of other significant concomitant illness(es) that, according to Investigator’s judgment, would adversely affect the patient’s participation in the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis MedDRA version: 15.1
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 131.6- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab Other descriptive name: RoActemra Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in patients with rheumatoid arthritis (RA) who are inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
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Primary end point(s): Safety as measured by adverse events/serious adverse events, physical examinations, clinical laboratory, ECGs.
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Timepoint(s) of evaluation of this end point: Up to 24 weeks
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Secondary Objective: Not applicable
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Not applicable
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Secondary end point(s): Not applicable
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Secondary ID(s)
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2012-003536-23-CZ
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SFY13370
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Source(s) of Monetary Support
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sanofi-aventis Recherche & Développement
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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