Remission after suspension of TNF alpha therapies in RA
- Conditions
- RHEUMATOID ARTHRITIS (RA) PATIENTSMedDRA version: 23.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-003129-40-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1. Able to comply and give informed consent;
2. Age > 18 and < 70 years;
3. diagnosis of RA according to ACR Criteria
4. clinical remission since at least 12 months (DAS 28 = 2.6, ACR remission criteria)
5. current therapy with anti TNF-alpha (adalimumab, etanercept o infliximab, certolizumab pegol, golimumab) from at least 15 months
6. = 6 mg/die of 6-methylprednisolone at stable dose for at least 3 months.
7. if the patient takes stable DMARDs (Methotrexate or Leflunomide or Hydroxicloroquine) therapy they must be at a stable dose for at least 3 months.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Exclusion criteria already provided for anti TNF alpha therapy (such as Tubercolosis, Hepatitis B or C and HIV infection)
2. Previous treatment with biological drugs (i.e. Rituximab, Tocilizumab, Abatacept)
3. Concomitant other systemic autoimmune diseases.
4. Functional status class IV classified according to the American College of Rheumatology 1991 revised criteria
5. Pregnant women or nursing (breast feeding) mothers.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method