EUCTR2018-003162-13-IT
Active, Not Recruiting
Phase 1
A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
- Enrollment
- 30
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years
- •Signed and dated informed consent
- •RA diagnosis according to ACR/EULAR 2010 criteria
- •Disease onset within 3 years
- •Tofacitinib oral therapy required due to synthetic or biologic DMARD
- •failure/intolerance according to EULAR recommendations
- •Glucocorticoid daily dose stable for at least 3 months and \= 5 mg/day of
- •prednisolone equivalent.
- •Unregarding ACPA status (both positive and negative included).
- •Wash out from previous biologic agent \= 3 half lives of the biologic agent and at
Exclusion Criteria
- •Other rheumatic diagnosis other than RA
- •Bone diseases other than osteoporosis
- •Severe liver or kidney disease
- •Not\-controlled endocrine disease
- •Contraindication to tofacitinib (concomitant recurrent or chronic infections,
- •tumor in the previous 5 years)
- •Previous treatment with other biologic agents within 3 months or 3 half lives of
- •the last one
- •Concomitant (or before 12 months, except for zoledronate that is before 24
- •months) treatment with bisphosphonate, strontium ranelate, teriparatide, selective
Outcomes
Primary Outcomes
Not specified
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