L-carnitine Supplementation in Rheumatoid Arthritis Patients

NCT06753565 | Recruiting Phase 2

• 1 other identifier: RACAR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis; Carnitine; anti-inflammatory; anti-oxidant; ACR50%; disease activity

Outcome Measures

Primary Outcomes (1)

• change in DAS28 ESR for both arms

  DAS 28-ESR is a score used to measure disease activity in RA patients. it is calculated using an equation where number of tender joints ( out of 28 joints) , number of swollen joints ( out of 28 joints) , patient assessment of disease activity ( using visual analogue scale from zero to 10) and ESR level are used as inputs to give DAS 28-ESR as output . the score will be measured to all participants both at baseline and at end of study. Higher scores indicate higher disease activity .

  From enrollment to the end of trial at 12 weeks

Secondary Outcomes (6)

• proportion of patients achieving ACR50% in both arms

  From enrollment to the end of trial at 12 weeks

• change in HAQ DI for both arms

  From enrollment to the end of trial at 12 weeks

• change in TNF aplha for both arms

  From enrollment to the end of trial at 12 weeks

• change in MDA for both arms

  From enrollment to the end of trial at 12 weeks

• change in TAC for both arms

  From enrollment to the end of trial at 12 weeks

Study Arms (2)

l-carnitine and conventional DMARDs

EXPERIMENTAL

l-carnitine 500 mg ( carnitine tartrate 500 mg) two capsules twice daily for three months as add on therapy to conventional DMARDs.

Drug: Carnitine; Drug: Disease-modifying anti-rheumatic drugs

placebo and conventional DMARDs

PLACEBO COMPARATOR

placebo 500 mg two capsules twice daily for three months as add on therapy to conventional DMARDs.

Drug: Disease-modifying anti-rheumatic drugs

Interventions

Carnitine DRUG

It is a nutritional supplement with trade name " Carnitol®" in Egypt.

l-carnitine and conventional DMARDs

Disease-modifying anti-rheumatic drugs DRUG

They are immunosuppressive drugs used to improve disease activity in Rheumatoid Arthritis patients . Conventional DMARDs include methotrexate (Imutrexate®) , leflunomide(Arthfree®) , hydroxychloroquine (plaquenil®) and sulfasalazine(colosalazine®) .

l-carnitine and conventional DMARDs; placebo and conventional DMARDs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18-60 years old
• diagnosed of rheumatoid arthritis according to 2010 American College of Rheumatology/European League Against Rheumatism criteria for at least 6 months
• enrolled patients treated with one of more of conventional DMARDs for ≥ 6 months with stable dose for ≥ 1 month before start of the study
• active RA despite conventional DMARDs treatment (DAS28 ESR more than or equal 3.2)
• patient or legal representative should sign informed consent

You may not qualify if:

• pregnant or lactating female
• patients with liver dysfunction (\>1.5x the upper limit of normal value for ALT \& AST)
• Patients with kidney dysfunction (serum creatinine more than 1.2 mg/dl)
• Patients with any active infection or concurrent malignancy
• patients with uncontrolled medical conditions or other rheumatic diseases
• patients currently taking drugs that could interact with carnitine like: warfarin

Sponsors & Collaborators

• German University in Cairo: lead

Study Sites (1)

Demerdash hospital

Cairo, Demerdash, Egypt

RECRUITING

Related Publications (11)

• Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137-45. doi: 10.1002/art.1780230202.

  PMID: 7362664 BACKGROUND

• Smolen JS, Landewe RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, McInnes IB, Sepriano A, van Vollenhoven RF, de Wit M, Aletaha D, Aringer M, Askling J, Balsa A, Boers M, den Broeder AA, Buch MH, Buttgereit F, Caporali R, Cardiel MH, De Cock D, Codreanu C, Cutolo M, Edwards CJ, van Eijk-Hustings Y, Emery P, Finckh A, Gossec L, Gottenberg JE, Hetland ML, Huizinga TWJ, Koloumas M, Li Z, Mariette X, Muller-Ladner U, Mysler EF, da Silva JAP, Poor G, Pope JE, Rubbert-Roth A, Ruyssen-Witrand A, Saag KG, Strangfeld A, Takeuchi T, Voshaar M, Westhovens R, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):685-699. doi: 10.1136/annrheumdis-2019-216655. Epub 2020 Jan 22.

  PMID: 31969328 BACKGROUND

• Yamanaka H, Tanaka E, Nakajima A, Furuya T, Ikari K, Taniguchi A, Inoue E, Harigai M. A large observational cohort study of rheumatoid arthritis, IORRA: Providing context for today's treatment options. Mod Rheumatol. 2020 Jan;30(1):1-6. doi: 10.1080/14397595.2019.1660028. Epub 2019 Oct 1.

  PMID: 31475852 BACKGROUND

• Jiang F, Zhang Z, Zhang Y, Wu J, Yu L, Liu S. L-carnitine ameliorates the liver inflammatory response by regulating carnitine palmitoyltransferase I-dependent PPARgamma signaling. Mol Med Rep. 2016 Feb;13(2):1320-8. doi: 10.3892/mmr.2015.4639. Epub 2015 Dec 4.

  PMID: 26647854 BACKGROUND

• Kiziltunc A, Cogalgil S, Cerrahoglu L. Carnitine and antioxidants levels in patients with rheumatoid arthritis. Scand J Rheumatol. 1998;27(6):441-5. doi: 10.1080/030097498442271.

  PMID: 9855215 BACKGROUND

• Conforti A, Di Cola I, Pavlych V, Ruscitti P, Berardicurti O, Ursini F, Giacomelli R, Cipriani P. Beyond the joints, the extra-articular manifestations in rheumatoid arthritis. Autoimmun Rev. 2021 Feb;20(2):102735. doi: 10.1016/j.autrev.2020.102735. Epub 2020 Dec 17.

  PMID: 33346115 BACKGROUND

• Bongartz T, Nannini C, Medina-Velasquez YF, Achenbach SJ, Crowson CS, Ryu JH, Vassallo R, Gabriel SE, Matteson EL. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum. 2010 Jun;62(6):1583-91. doi: 10.1002/art.27405.

  PMID: 20155830 BACKGROUND

• Sayah A, English JC 3rd. Rheumatoid arthritis: a review of the cutaneous manifestations. J Am Acad Dermatol. 2005 Aug;53(2):191-209; quiz 210-2. doi: 10.1016/j.jaad.2004.07.023.

  PMID: 16021111 BACKGROUND

• Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016 Oct 22;388(10055):2023-2038. doi: 10.1016/S0140-6736(16)30173-8. Epub 2016 May 3.

  PMID: 27156434 BACKGROUND

• Klareskog L, Ronnelid J, Saevarsdottir S, Padyukov L, Alfredsson L. The importance of differences; On environment and its interactions with genes and immunity in the causation of rheumatoid arthritis. J Intern Med. 2020 May;287(5):514-533. doi: 10.1111/joim.13058.

  PMID: 32176395 BACKGROUND

• Crowson CS, Matteson EL, Myasoedova E, Michet CJ, Ernste FC, Warrington KJ, Davis JM 3rd, Hunder GG, Therneau TM, Gabriel SE. The lifetime risk of adult-onset rheumatoid arthritis and other inflammatory autoimmune rheumatic diseases. Arthritis Rheum. 2011 Mar;63(3):633-9. doi: 10.1002/art.30155.

  PMID: 21360492 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Carnitine; Antirheumatic Agents

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)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Mariam Ehab, Master

CONTACT

+2001223360548; mariam.ehab-azmy@guc.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 31, 2024
• Study Start: December 31, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

EG (1)