Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal)

Conditions: Rheumatoid Arthritis
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Registration Number: EUCTR2015-002523-26-HU

Lead Sponsor: Arthritis Alapítvány

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Adults (>18 years) male or female
- Obtained consent from patient in written form
- Existing rheumatoid arthritis for more than 6 months (DAS28 >3,2), with preceding biological therapy for at least 3 months
- Patients able to attend to control examinations and fulfil the requirements of protocol
- Patients able to understand and fill the optional questionnaires
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Uncertain diagnosis
- Severe allergic or anaphylactic raction, or hypersensitivity to any component of tofacitinib
- Any active or clinically significant recurrent infection
- Contraindications of tofacitinib therapy (heart failure, SLE, demyelinating diseases, history of malignacy in 10 years, kidney failure, liver failure)
- Pregnancy
- History of current symptoms of any untreated disease (e.g. unstable hypertension, diabetes mellitus), which puts the patient at risk in opinion of the investigator doctor
- Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation.