Inhibition of JAK Enzymes in early stage Joint inflammation

JAK Inhibition in PReclinical Arthritis - JAKIPRA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006562-20-DE

Enrollment

Registered

2022-08-08

Start date

2022-10-26

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Preclinical Phase of rheumatoid arthritis MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Olumiant 2 mg/4 mg Filmtabletten Product Name: Baricitinib blinded Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Baricitinib CAS Number: 1187594-09-7 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Clinical: no arthritis in 76/78 joint count • Imaging: = 1 B-Mode or PD (Power Doppler) signal with ultrasound at one of the 76/78 joints or flexor/extensor tendons of hand or feet • Autoantibodies: (2 different Autoantibodies are compulsory, one of them anti-CCP antibodies) o Anti-CCP antibody positivity at Screening o Anti-modified antibodies: (citrullinated vimentin, citVIM; citrullinated a-enolase, citENO; citrullinated fibrinogen alpha, citFIBa; citrullinated fibrinogen beta, citFIBb) (carbamylated vimentin, carVIM; ornithine acetylated vimentin (ac-orn VIM) and lysine acetylated Vimentin, ac-lys VIM)or RF • Genetics: HLA Status with positive risk allel for RA such as HLA DRB1*01,*02,*03,…*015 • female or male patients, at least 18 and at most 64 years of age 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 5

Exclusion criteria

Exclusion criteria: • Clinically apparent arthritis (76/78 joint count) • Fulfilment of ACR/EULAR 2010 Classification Criteria for RA • Any previous therapy with bDMARD/tsDMARD/cDMARD • Ongoing pregnancy status or breast-feeding • Contraindication for Baricitinib treatment according to its SmPC • Any malignancy risk factor (e.g. current malignancy or history of malignancy) • Any active, chronic or recurrent infection • Any pre-existing condition that constitutes a risk factor for major adverse cardiovascular events (e.g. history of stroke, coronary heart disease, myocardial infarction, current or past long-time smoker) • Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of JAK Inhibition with baricitinib in preclinical stage of arthritis;Secondary Objective: • To evaluate the effect of serological biomarkers such as pro-inflammatory cytokines, interferon signatures, bone biomarkers in preclinical arthritis • To evaluate safety of baricitinib in preclinical stage of arthritis • To identify (imaging and serological) biomarkers which may predict the course of disease in preclinical stage of arthritis • To evaluate the effect of baricitinib on physical (hand) function in preclinical stage of disease ;Primary end point(s): Number of patients with development of arthritis ;Timepoint(s) of evaluation of this end point: week 48	—

Measure

Time frame

Main Objective: To evaluate the effect of JAK Inhibition with baricitinib in preclinical stage of arthritis;Secondary Objective: • To evaluate the effect of serological biomarkers such as pro-inflammatory cytokines, interferon signatures, bone biomarkers in preclinical arthritis • To evaluate safety of baricitinib in preclinical stage of arthritis • To identify (imaging and serological) biomarkers which may predict the course of disease in preclinical stage of arthritis • To evaluate the effect of baricitinib on physical (hand) function in preclinical stage of disease ;Primary end point(s): Number of patients with development of arthritis ;Timepoint(s) of evaluation of this end point: week 48

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Secondary

Measure	Time frame
Secondary end point(s): • Number of patients with development of arthritis at week 24 • Fulfillment of the ACR/EULAR 2010 RA classification criteria • Imaging: o Ultrasound: Number of participants without signs of PD Synovitis or PD Tenosynovitis at week 24 and 48 compared to baseline and compared within both groups • Explorative serological biomarkers: (week 24 and week 48 compared to baseline) o Change in anti CCP2 antibody levels (RE/ml) o Change in anti CCP2 antibodies in HLA-defined subgroups o Glycosylation profile of total IgG, and CCP2 antibodies o Number and frequency of total and CCP2-specific B cells o MS-based unbiased metabolic profiling of plasma metabolites o Changes in GBP1 levels • Clinical outcomes, physical function and PROs: o Patients without tender joints at week 48 compared to baseline o Joint count 76/78; HAQ; SDAI/CDAI/DAS28-CRP o Pain: VAS global, VAS pain, VAS physician o Subjective (SACRAH, sMHQ) and objective (moberg-pick up test (MPUT)) hand function o Safety ;Timepoint(s) of evaluation of this end point: week 24 / week 48 compared to baseline	—

Measure

Time frame

Secondary end point(s): • Number of patients with development of arthritis at week 24 • Fulfillment of the ACR/EULAR 2010 RA classification criteria • Imaging: o Ultrasound: Number of participants without signs of PD Synovitis or PD Tenosynovitis at week 24 and 48 compared to baseline and compared within both groups • Explorative serological biomarkers: (week 24 and week 48 compared to baseline) o Change in anti CCP2 antibody levels (RE/ml) o Change in anti CCP2 antibodies in HLA-defined subgroups o Glycosylation profile of total IgG, and CCP2 antibodies o Number and frequency of total and CCP2-specific B cells o MS-based unbiased metabolic profiling of plasma metabolites o Changes in GBP1 levels • Clinical outcomes, physical function and PROs: o Patients without tender joints at week 48 compared to baseline o Joint count 76/78; HAQ; SDAI/CDAI/DAS28-CRP o Pain: VAS global, VAS pain, VAS physician o Subjective (SACRAH, sMHQ) and objective (moberg-pick up test (MPUT)) hand function o Safety ;Timepoint(s) of evaluation of this end point: week 24 / week 48 compared to baseline

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Countries

Germany

Contacts

Public ContactMedizinische Klinik 3

Universitätsklinikum Erlangen

daniela.bohr@uk-erlangen.de004991318543244

Outcome results

None listed

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