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

• Register: EUCTR
• Last refreshed on: 21 October 2024
• Main ID: EUCTR2018-003162-13-IT
• Date of registration: 08/11/2018
• Prospective Registration: Yes
• Primary sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
• Public title: A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib
• Scientific title: A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128
• Date of first enrolment: 23/01/2019
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003162-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Italy

Contacts

• Name: Unità Ricerca Clinica
• Affiliation: AOUI Verona

• Name: Unità Ricerca Clinica
• Affiliation: AOUI Verona

Key inclusion & exclusion 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:
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

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: TOFACITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: M0 vs M1, M2, M3, M6, M9, M12

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)

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)

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: M0, M1, M2, M3, M6, M9, M12

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

Secondary ID(s)

WI232128

Source(s) of Monetary Support

Pfizer S.r.l.

Ethics review

Status: Approved
Approval date: 23/01/2019
Contact: