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

NCT06977035 | Not Yet Recruiting

• 1 other identifier: Soh--Med--25-4-09MS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• prevalence of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib

  Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib in comparison to those on conventional synthetic DMARDs.

  6 months

Study Arms (2)

Rheumatoid Arthritis patients on Baricitinib treatment

ACTIVE COMPARATOR

Device: Nerve Conduction Study

Rheumatoid Arthritis patient on conventional synthetic DMARD

ACTIVE COMPARATOR

Device: Nerve Conduction Study

Interventions

Nerve Conduction Study DEVICE

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

Rheumatoid Arthritis patient on conventional synthetic DMARD; Rheumatoid Arthritis patients on Baricitinib treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other rheumatologic or collagen diseases.
• Age below 18 years and above 65 years.
• Uncooperative patients.
• Patients with other causes of peripheral neuropathy as Diabetes mellitus.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• 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.

  PMID: 38240831 BACKGROUND

• 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.

  PMID: 9652497 BACKGROUND

• 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.

  PMID: 29687421 BACKGROUND

• 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.

  PMID: 15961865 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Sara K Mohamed, Resident

CONTACT

01155791113; sara.khairy@med.sohag.edu.eg

Ahmed R Alagamy, Associate Professor

CONTACT

01092914019; ahmed_radwan@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Physical medicine, Rheumatology and Rehabilitation Department, Sohag University Hospital

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 16, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05