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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002523-26-HU

Enrollment

Registered

2015-11-13

Start date

2016-03-08

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Tofacitinib Product Code: CP-690,55-10 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessing the vascular imaging markers FMD, ccIMT and PWV at baseline and then after 1, 6 and 12 months of therapy. Assessing the vasculature and joints by whole body PET-CT imaging at baseline and after 12 months of therapy. Identifying correlation of synovial and vascular inflammatory changes assessed by PET-CT. Recording any cardio- or cerebrovascular disease occurring at any time during the follow-up and to extend the follow-up for 5 years after baseline.;Secondary Objective: Assessing bone density by DEXA, and, in order to determine bone density in trabecular and cortical bone separately, also by radius pqCT at baseline and after 6 and 12 months of treatment. Assessing laboratory markers of bone formation (osteocalcin), resorption (NTX, CTX), as well as molecular markers of osteoimmunology (RANKL, OPG, DKK-1 and sclerostin) at baseline and after 1, 3, 6 and 12 months of therapy.;Primary end point(s): Primary endpoint: surrogate markers of vascular pathology after 12 months of TOF treatment. Assessing clinical activity by DAS28, and obtaining peripheral blood samples for detailed analysis of disease activity and metabolic profile including BMI, CRP, ACPA, RF, homocysteine, full lipid profile, inflammatory HDL, paraoxonase 1 (PON-1), folate, vitamin B12, insulin, resistin, adiponectin, leptin, as well as methylene tetrahydrofolate (MTHFR) and paraoxonase gene polymorphisms. Assessing PWV indicating vascular stiffness at baseline and then after 6 and 12 months of therapy. Assessing the vasculature and joints by whole body PET-CT imaging at baseline and after 12 months of therapy. Correlation of synovial and vascular inflammatory changes will be assessed by PET-CT.;Timepoint(s) of evaluation of this end point: Clinical assessment and lab will be performed at baseline, Months 6 and 12. Vascular imaging (ccIMT, PWV, FMD) will be assessed at baseline, Months 6 and 12. PET-CT will be performed twice, at baseline and Months 12.	—

Measure

Time frame

Main Objective: Assessing the vascular imaging markers FMD, ccIMT and PWV at baseline and then after 1, 6 and 12 months of therapy. Assessing the vasculature and joints by whole body PET-CT imaging at baseline and after 12 months of therapy. Identifying correlation of synovial and vascular inflammatory changes assessed by PET-CT. Recording any cardio- or cerebrovascular disease occurring at any time during the follow-up and to extend the follow-up for 5 years after baseline.;Secondary Objective: Assessing bone density by DEXA, and, in order to determine bone density in trabecular and cortical bone separately, also by radius pqCT at baseline and after 6 and 12 months of treatment. Assessing laboratory markers of bone formation (osteocalcin), resorption (NTX, CTX), as well as molecular markers of osteoimmunology (RANKL, OPG, DKK-1 and sclerostin) at baseline and after 1, 3, 6 and 12 months of therapy.;Primary end point(s): Primary endpoint: surrogate markers of vascular pathology after 12 months of TOF treatment. Assessing clinical activity by DAS28, and obtaining peripheral blood samples for detailed analysis of disease activity and metabolic profile including BMI, CRP, ACPA, RF, homocysteine, full lipid profile, inflammatory HDL, paraoxonase 1 (PON-1), folate, vitamin B12, insulin, resistin, adiponectin, leptin, as well as methylene tetrahydrofolate (MTHFR) and paraoxonase gene polymorphisms. Assessing PWV indicating vascular stiffness at baseline and then after 6 and 12 months of therapy. Assessing the vasculature and joints by whole body PET-CT imaging at baseline and after 12 months of therapy. Correlation of synovial and vascular inflammatory changes will be assessed by PET-CT.;Timepoint(s) of evaluation of this end point: Clinical assessment and lab will be performed at baseline, Months 6 and 12. Vascular imaging (ccIMT, PWV, FMD) will be assessed at baseline, Months 6 and 12. PET-CT will be performed twice, at baseline and Months 12.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint: surrogate markers of bone pathology after 12 months of TOF treatment. Assessing bone density by DEXA, and, in order to determine bone density in trabecular and cortical bone separately, also by radius pqCT at baseline and after 12 months of treatment. Assessing laboratory markers of bone formation (osteocalcin), resorption (NTX, CTX), and molecular markers of osteoimmunology (RANKL, OPG, DKK-1 and sclerostin) at baseline and after 6 and 12 months of therapy. ;Timepoint(s) of evaluation of this end point: DEXA and pqCT will perfomed at baseline and Month 12. Bone markers will be assessed at baseline, Months 6 and 12.	—

Measure

Time frame

Secondary end point(s): Secondary endpoint: surrogate markers of bone pathology after 12 months of TOF treatment. Assessing bone density by DEXA, and, in order to determine bone density in trabecular and cortical bone separately, also by radius pqCT at baseline and after 12 months of treatment. Assessing laboratory markers of bone formation (osteocalcin), resorption (NTX, CTX), and molecular markers of osteoimmunology (RANKL, OPG, DKK-1 and sclerostin) at baseline and after 6 and 12 months of therapy. ;Timepoint(s) of evaluation of this end point: DEXA and pqCT will perfomed at baseline and Month 12. Bone markers will be assessed at baseline, Months 6 and 12.

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Countries

Hungary

Contacts

Public Contactpresident

Arthritis Alapítvány

reuma.titkarsag@med.unideb.hu3652255091

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026