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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03100253
Date of registration: 17/03/2017
Prospective Registration: Yes
Primary sponsor: Mario Negri Institute for Pharmacological Research
Public title: Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation RAFTING
Scientific title: 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
Date of first enrolment: March 1, 2018
Target sample size: 208
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03100253
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Italy
Contacts
Name:     Carlo Scirè
Address: 
Telephone: +390239014519
Email: c.scire@reumatologia.it
Affiliation: 
Name:     Mauro Galeazzi
Address: 
Telephone:
Email:
Affiliation:  Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
Key inclusion & exclusion 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: 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; secondary non-response: determined by physician decision with
evidence of flare and deterioration in DAS28 of = 1.2.

- 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.

- Signed written informed consent for biological analysis.

- Female patients with reproductive potential must have a negative serum pregnancy test
within 7 days prior to start of trial. Women of childbearing potential and male
patients must be willing to practice acceptable methods of contraception during
treatment and for 6 months (female patients) and 3 months (male patients) after
discontinuation of treatment.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Adalimumab
Drug: Certolizumab Pegol
Drug: Etanercept
Drug: Golimumab
Drug: Infliximab
Drug: Tocilizumab
Primary Outcome(s)
Proportion of patients with good EULAR [Time Frame: 24 weeks]
Secondary Outcome(s)
Health Assessment Questionnaire (HAQ) score [Time Frame: 24 weeks]
Health Assessment Questionnaire (HAQ) score [Time Frame: 48 weeks]
Health Assessment Questionnaire (HAQ) score [Time Frame: 96 weeks]
Proportion of patients with a good/moderate EULAR [Time Frame: 12 weeks]
Proportion of patients with a good/moderate EULAR [Time Frame: 24 weeks]
Proportion of patients with a remission according to DAS28/SDAI/CDAI [Time Frame: 24 weeks]
Proportion of patients with a remission according to DAS28/SDAI/CDAI [Time Frame: 48 weeks]
Proportion of patients with a remission according to DAS28/SDAI/CDAI [Time Frame: 96 weeks]
Proportion of patients with ACR20/50/70 response [Time Frame: 12 weeks]
Proportion of patients with ACR20/50/70 response [Time Frame: 24 weeks]
Van Der Heijde Modified Total Sharp Score [X-ray score] [Time Frame: 48 weeks]
Van Der Heijde Modified Total Sharp Score [X-ray score] [Time Frame: 96 weeks]
Secondary ID(s)
IRFMN-RA-6453
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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