NCT03701789

Brief Summary

Patients with Rheumatoid Arthritis (RA) suffer systemic and peripheral bone loss. In this study we aim to test the efficacy of in-label treatment with Baricitinib on the volumetric bone mineral density in patients with RA over 52 weeks. Inclusion of RA patients comprises pathologic volumetric bone mineral density measured by (High Resolution peripheral quantitative Computed Tomomgraphy) HR-pQCT maging of finger joints.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Sep 2018

Typical duration for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3.1 years

First QC Date

October 4, 2018

Last Update Submit

January 14, 2021

Conditions

Rheumatoid ArthritisBone DensityFinger Joints

Outcome Measures

Primary Outcomes (1)

  • Change in volumetric bone mineral density (vBMD) in metacarpal and radial bone between baseline and week 52 in patients with rheumatoid arthritis treated with baricitinib as determined by HR-pQCT

    HR-pQCT

    52 weeks

Study Arms (1)

Patients with Rheumatoid Arthritis

OTHER

In-label treatment with Baricitinib

Drug: Baricitinib

Interventions

BaricitinibDRUG

Effect of Baricitinib on vBMD measured by HR-pQCT

Also known as: Oliumiant
Patients with Rheumatoid Arthritis

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be able to understand and communicate with the investigator and comply with the requirements of the study, must give a written and signed and dated informed consent before any study assessment is performed
  • Male or non-pregnant, non-lactating female subjects aged between 18 - 74
  • Women of childbearing potential must oblige to use a highly effective method of birth control until at least 4 weeks after the last IMP administration
  • Diagnosis of RA according to the ACR/EULAR criteria and with symptoms for at least 3 months with moderate to severe RA
  • pathologic volumetric bone density, microstructure or presence of erosions detected by HR-pQCT and or MRI measurement
  • Previous treatment with at least one DMARD (e.g. methotrexate) without sufficient clinical response or stopped due to toxicities
  • Fulfil criteria for baricitinib treatment according to its SmPC

You may not qualify if:

  • Ongoing pregnancy status or breast-feeding
  • Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months or according to local guidelines, prior to screening and evaluated by a qualified physician
  • Contraindication for baricitinib treatment according to its SmPC
  • Current treatment with bDMARDs or other JAK-inhibitors
  • Creatinine clearance \< 60ml/min (calculated analogue MDRD)
  • Current treatment with OAT3 inhibitors
  • Participation in an interventional clinical trial with an IMP within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitiy Hospital Erlangen

Erlangen, Bavaria, 91052, Germany

Location

Related Publications (1)

  • Simon D, Minopoulou I, Kemenes S, Bayat S, Tascilar K, Mutlu MY, Valor-Mendez L, Kronke G, Hueber AJ, Schett G, Kleyer A. Baricitinib Improves Bone Properties and Biomechanics in Patients With Rheumatoid Arthritis: Results of the Prospective Interventional BARE BONE Trial. Arthritis Rheumatol. 2023 Nov;75(11):1923-1934. doi: 10.1002/art.42617. Epub 2023 Sep 21.

    PMID: 37229650DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Arnd Kleyer, MD

    Department of Internal Medicine 3, Rheumatology and Immunology Universital Hospital Erlangen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 10, 2018

Study Start

September 11, 2018

Primary Completion

October 11, 2021

Study Completion

October 11, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)