A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-003162-13-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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
least 3 months.
• women of childbearing age must have a negative urine pregnancy test within 7 days
before beginning treatment and they will be informed of the need of an efficacy
contraceptive method during the administration and after 4 weeks from the last dose of
tofacitinib
• patients must be negative to screening exam for latent infections ( HIV, HCV, HBV,
quantiferon, chest x-rays)
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
estrogen receptor modulators (SERM) or denosumab.
• Intra-articular injections at MCPs or MTPs in the 3 months before.
• Pregnancy or breast feeding status
• Prisoners or subjects who are compulsory detained

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified