EUCTR2016-001987-12-IT
Active, not recruiting
Phase 1
Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING
SOCIETA' ITALIANA DI REUMATOLOGIA - SIR0 sites208 target enrollmentJanuary 5, 2021
ConditionsRHEUMATOID ARTHRITISMedDRA version: 20.0Level: LLTClassification code 10037738Term: R arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 20.0Level: LLTClassification code 10039014Term: Rh arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 23.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINOENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZREMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EVHUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOLCIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- RHEUMATOID ARTHRITIS
- Sponsor
- SOCIETA' ITALIANA DI REUMATOLOGIA - SIR
- Enrollment
- 208
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Age \=18 years at the time of signing the informed consent form and either male or female
- •\-Diagnosis of RA according to the 1987 ACR classification criteria OR 2010 ACR/EULAR classification criteria at least 6 months prior to screening
- •\-Patients with persistent RA disease activity whilst being treated with an initial TNFi agent on a background MTX up to 20\-25 mg/week for at least 12 weeks defined according to SIR and EULAR guidelines as:
- •A)Primary non\-response: failing to improve DAS28 by \= 1\.2 or failing to achieve DAS28 \= 3\.2 within the first three to six months of starting the initial TNFi;
- •B)Secondary non\-response: determined by physician decision with evidence of flare and deterioration in DAS28 of \= 1\.2
- •C)Drug withdrawal for adverse events (not contraindicating a second course of TNFi (not class\-adverse events))
- •\-Methotrexate (MTX) dose stable for 28 days prior to screening
- •\-Patients on NSAIDs and / or corticosteroids must remain on an unchanged regimen for at least 28 days prior to study drug administration
- •\-The patient must be able to comply with the study visit schedule and other protocol requirements
- •\-The patient understands the purpose of the study and is able and willing to sign the informed consent form, according to ICH/GCP
Exclusion Criteria
- •\-Patients who have previously received more than 1 TNFi drug OR any other biological therapy
- •\-Patients with inflammatory joint disease of different origin or any arthritis with onset prior to 16 years of age
- •\-Patients taking any disease\-modifying antirheumatic drug (DMARDs) (e.g. all except methotrexate). Discontinuation must occur at least 28 days prior to study treatment start
- •\-History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
- •\-Known hypersensitivity to any active substance or excipients of study drug
- •\-Pregnancy or breast feeding.
Outcomes
Primary Outcomes
Not specified
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