Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: XELJANZ 5 mg film-coated tablets
Product Name: Xeljanz 5mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TOFACITINIB
CAS Number: 477600-75-2
Current Sponsor code: TOFACITINI
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of our study is to investigate the effect of tofacitinib on serum levels of bone turnover markers (CTX ng/ml, P1NP ng/ml, BAP ng/ml) and modulators (DKK1 pmol/L, Sclerostin pmol/L, OPG pmol/L, RANKL pmol/L, PTH pg/ml, 25 OH vitamin D ng/ml);Secondary Objective: 1. changes versus baseline in hip and lumbar bone mineral density (BMD) by Dual X-ray Absorptiometry (DXA), hand BMD by DXR, bone erosions and anti-citrullinated peptides antibodies (ACPA), 2. to investigate the correlations between ACPA, bone turnover markers and modulators (BTM), bone mineral density (BMD) by Dual X-ray Absoptiometry (DXA), metacarpal index (MCI) and Bone Health Index (BHI) by and Digital X-ray Radiogrammometry (DXR), and bone erosions in patients with RA with short disease duration. 3. to evaluate the influence of tofacitinib on those outcomes and determinate if they are related to the effect on ACPA titer;Primary end point(s): Serum levels of bone turnover markers (CTX ng/ml, P1NP ng/ml, BAP ng/ml) and modulators (DKK1 pmol/L, Sclerostin pmol/L, OPG pmol/L, RANKL pmol/L, PTH pg/ml, 25 OH vitamin D ng/ml) serum levels at multiple timepoints (M1, M2, M3, M6, M9 e M12) versus pre-treatment levels (M0);Timepoint(s) of evaluation of this end point: M0 vs M1, M2, M3, M6, M9, M12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Systemic BMD (lumbar e femoral T and Z-scores) and hand MCI/BHI, evaluation of bone erosions (Sharp van der Heijde Score), RF U/ml, ACPAU/ml at multiple timepoints (M0, M1, M2, M3, M6, M9 e M12). These endpoints refers to secondary objectives 1., 2., 3;Timepoint(s) of evaluation of this end point: M0, M1, M2, M3, M6, M9, M12 | — |
Countries
Italy
Contacts
Public ContactUnità Ricerca Clinica
AOUI Verona
Outcome results
None listed