Rheumatoid ArthritisNCT06977035
Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib
A study testing Nerve Conduction Study in people with Rheumatoid Arthritis, run by Sohag University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Nerve Conduction Study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfill the 2010 ACR/EULAR classification criteria of RA
- Age above 18 years old.
- Patient cooperative and can answer questions
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor, 0934602963, portal@med.sohag.edu.eg
About this study
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
- Being tested
- Nerve Conduction Study
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Conduction StudyDevice
Sensory and Motor Nerve Conduction study on upper and lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis patients on Baricitinib treatment | Active comparator | Not described Receives: Device: Nerve Conduction Study |
| Rheumatoid Arthritis patient on conventional synthetic DMARD | Active comparator | Not described Receives: Device: Nerve Conduction Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start5 May 2025
- Primary completion5 Nov 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Khairy Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977035
- Sponsor's protocol ID
- Soh--Med--25-4-09MS
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38240831Grassi 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.
PubMed 9652497Al-Salama ZT, Scott LJ. Baricitinib: A Review in Rheumatoid Arthritis. Drugs. 2018 May;78(7):761-772. doi: 10.1007/s40265-018-0908-4.
PubMed 29687421Mallik 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.
PubMed 15961865
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib
- ClinicalTrials.gov ID
- NCT06977035
- Acronym / sponsor ID
- Soh--Med--25-4-09MS
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients fulfill the 2010 ACR/EULAR classification criteria of RA
- Age above 18 years old.
- Patient cooperative and can answer questions
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve Conduction StudySensory and Motor Nerve Conduction study on upper and lower limbs. | Device | Rheumatoid Arthritis patient on conventional synthetic DMARD, Rheumatoid Arthritis patients on Baricitinib treatment |
Primary outcome
prevalence of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib
Time frame: 6 months
Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib in comparison to those on conventional synthetic DMARDs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 38240831Di 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.
- Background: PubMed 9652497Grassi 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.
- Background: PubMed 29687421Al-Salama ZT, Scott LJ. Baricitinib: A Review in Rheumatoid Arthritis. Drugs. 2018 May;78(7):761-772. doi: 10.1007/s40265-018-0908-4.
- Background: PubMed 15961865Mallik 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Conduction Study in people with Rheumatoid Arthritis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara K Mohamed, Resident (01155791113, sara.khairy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06977035, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.