se of tofacitinib in patients with treatment-refractory rheumatoid arthritis.
- Conditions
- Refractory rheumatoid arthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-001560-14-ES
- Lead Sponsor
- FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 42
1. Patients, male or female, over 18 years of age.
2. Patients capable of providing written informed consent.
3. Patients mentally competent to understand and agree to carry out the study procedures, as well as tolerate blood draws, local anesthesia, and synovial biopsy.
4. Patients diagnosed with rheumatoid arthritis according to the ACR / EULAR 2010 classification criteria.
5. Patients with active rheumatoid arthritis (DAS28> 3.2) with at least 3 painful and swollen joints out of the 28 joints evaluated in the DAS28 (shoulders, elbows, carpals, metacarpophalangeal, proximal interphalangeal of the hands and knees), in which at least one of them is among the following: carpals, 2nd metacarpophalangeal and knees, and in which the presence of synovial hypertrophy at least grade 2 (on a scale of 0-3) is confirmed by ultrasound.
6. Patients with refractory rheumatoid arthritis, defined as failure to one or more classic synthetic DMARDs (methotrexate, leflunomide, sulfasalazine, leflunomide, or hydroxychloroquine) followed by failure to one or more biological DMARDs (TNF, abatacept, tocilizumab, rituximab).
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 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
1. Diagnosis of another type of arthritis other than rheumatoid arthritis.
2. Contraindication to the use of targeted synthetic DMARDs (active infection, previously untreated latent tuberculosis, neoplasia). In cases of latent tuberculosis, after 1 month of tuberculosis treatment, the inclusion of the patient in the study could be considered.
3. Known allergy or hypersensitivity to tofacitinib.
4. Patients taking medications that may interact with tofacitinib or any other contrindication to the use of tofacitinib.
5. Patients in treatment with any drug that may affect the evaluation of the study. Patients must have a washout period prior to the start of the study. Unless there is intolerance, adverse effects, or other specific reason, patients can continue their treatment with classic synthetic DMARDs. In relation to the use of NSAIDs or corticosteroids, concomitant stable doses of NSAIDs or corticosteroids (less than / equal to 10mg of prednisone per day or its equivalent) will be allowed.
6. Anticoagulated patients.
7. Pregnant or lactating patients.
8. Patients participating in another clinical trial or who have participated in another clinical trial in the 3 months prior to signing the IC.
9. Known HIV, HBV, or HCV infection.
10. Patients considered in the investigator's judgment as ineligible for the study based on their medical history, physical examination, medication, and concomitant pathologies.
11. Potentially fertile women who are unwilling to use a contraceptive method that is considered effective *.
* A woman is considered to have reproductive potential (WOCBP), that is, fertile, after menarche and until she becomes postmenopausal, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
Highly effective methods are considered: combined hormonal contraception (containing estrogens and progestogens) associated with inhibition of ovulation (oral, intravaginal, transdermal route), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable ), intrauterine device (IUD), intrauterine hormone releasing system (IUS), bilateral tubal occlusion, vasectomized couple, sexual abstinence.
12. Patients who do not want to participate or are not willing to give their IC in writing.
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