NCT05792527

Brief Summary

This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2023

Typical duration for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 5, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 19, 2023

Last Update Submit

March 30, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • The change in DAS-28-CRP score

    Patients will undergo clinical assessment according to DAS-28-CRP score

    3 months

  • The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score

    3 months

Secondary Outcomes (3)

  • The change in serum level of C-reactive protein (CRP)

    3 months

  • The change in serum level of Signal transducer and activator of transcription 3(STAT 3).

    3 months

  • The change in serum level of Transforming growth factor β1(TGF-β1).

    3 months

Study Arms (2)

control group

NO INTERVENTION

this group will include 23 patients which will receive the traditional therapy of RA for 3 months.

L-carnitine group

ACTIVE COMPARATOR

this group will include 23 patients which will receive 500mg L-carnitine two times daily after meal plus the traditional therapy of RA for 3 months.

Drug: L-carnitine

Interventions

L-carnitineDRUG

One 500 mg tablet twice daily after meals

L-carnitine group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (9) i.e., 28 joints disease activity score (DAS-28) \>2.6.
  • Patients receive the conventional DMARDs
  • Both sexes.
  • Age range between 18 and 70 years old.

You may not qualify if:

  • Patients with heart disease (congestive heart failure, arrhythmia, hypertension, ischemic heart diseases), diabetes, active infection, other illness except rheumatoid arthritis.
  • Patients with renal and hepatic dysfunction.
  • Patients receiving biological DMARDs.
  • Patients receiving oral prednisolone greater than 15 mg/day.
  • Patients with hypersensitivity to study medications.
  • Patients using antioxidants.
  • Pregnant and lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, Gharbia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Carnitine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Central Study Contacts

Abdallah A Eldisouky

CONTACT

201279142631PG_165476@pharm.tanta.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 31, 2023

Study Start

March 5, 2023

Primary Completion

March 5, 2025

Study Completion

March 5, 2026

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

EG(1)