Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib

NCT ID: NCT06977035

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Rheumatoid arthritis is a chronic, systemic, autoimmune inflammatory disease that mainly affects the joints and periarticular soft tissues. Baricitinib (Olumiant®) is an oral, targeted synthetic DMARD that inhibits JAK1 and JAK2, which are implicated in the pathogenesis of rheumatoid arthritis (RA). Nerve conduction studies (NCSs) are an essential tool in the evaluation of the peripheral nervous system. The sensory nerve action potential (SNAP) provides information on the sensory nerve axon and its pathway from the distal receptors in the skin to the dorsal root ganglia, while the compound muscle action potential (CMAP) is an assessment of the motor nerve fibers from their origins in the anterior horn cell to their termination along muscle fibers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rheumatoid Arthritis patients on Baricitinib treatment

Group Type ACTIVE_COMPARATOR

Nerve Conduction Study

Intervention Type DEVICE

Sensory and Motor Nerve Conduction study on upper and lower limbs.

Rheumatoid Arthritis patient on conventional synthetic DMARD

Group Type ACTIVE_COMPARATOR

Nerve Conduction Study

Intervention Type DEVICE

Sensory and Motor Nerve Conduction study on upper and lower limbs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nerve Conduction Study

Sensory and Motor Nerve Conduction study on upper and lower limbs.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients fulfill the 2010 ACR/EULAR classification criteria of RA
2. Age above 18 years old.
3. Patient cooperative and can answer questions

Exclusion Criteria

1. Other rheumatologic or collagen diseases.
2. Age below 18 years and above 65 years.
3. Uncooperative patients.
4. Patients with other causes of peripheral neuropathy as Diabetes mellitus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sara Khairy Mohamed

Resident at Physical medicine, Rheumatology and Rehabilitation Department, Sohag University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sara K Mohamed, Resident

Role: CONTACT

01155791113

Ahmed R Alagamy, Associate Professor

Role: CONTACT

01092914019

References

Explore related publications, articles, or registry entries linked to this study.

Di Matteo A, Bathon JM, Emery P. Rheumatoid arthritis. Lancet. 2023 Nov 25;402(10416):2019-2033. doi: 10.1016/S0140-6736(23)01525-8. Epub 2023 Oct 27.

Reference Type BACKGROUND
PMID: 38240831 (View on PubMed)

Grassi W, De Angelis R, Lamanna G, Cervini C. The clinical features of rheumatoid arthritis. Eur J Radiol. 1998 May;27 Suppl 1:S18-24. doi: 10.1016/s0720-048x(98)00038-2.

Reference Type BACKGROUND
PMID: 9652497 (View on PubMed)

Al-Salama ZT, Scott LJ. Baricitinib: A Review in Rheumatoid Arthritis. Drugs. 2018 May;78(7):761-772. doi: 10.1007/s40265-018-0908-4.

Reference Type BACKGROUND
PMID: 29687421 (View on PubMed)

Mallik A, Weir AI. Nerve conduction studies: essentials and pitfalls in practice. J Neurol Neurosurg Psychiatry. 2005 Jun;76 Suppl 2(Suppl 2):ii23-31. doi: 10.1136/jnnp.2005.069138. No abstract available.

Reference Type BACKGROUND
PMID: 15961865 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh--Med--25-4-09MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.