Rheumatoid Arthritis (RA)Phase 2NCT06753565
L-carnitine Supplementation in Rheumatoid Arthritis Patients
A Phase 2 study testing Carnitine and Disease-modifying anti-rheumatic drugs in people with Rheumatoid Arthritis (RA), run by German University in Cairo at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Carnitine and Disease-modifying anti-rheumatic drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Dec 2024to Jun 2025
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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
Demerdash hospital
Cairo, Demerdash
Amr Hawwash, PhD, +2001123902218
About this study
Official title: Effect of L-carnitine Supplementation on Disease Activity in Rheumatoid Arthritis Patients
This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients.
Read the detailed description
Rheumatoid arthritis (RA) is an inflammatory autoimmune disease that affects joints of hand, wrist and foot. Its epidemiology is more pronounced in female to male in ratio 3:1 . Etiology of the disease is related to genetics and environmental factors that lead to formation of epitopes initiating autoimmune response . It is characterized by symmetrical polyarthritis in equal or more than 5 joints and it is known that long term inflammation leads to bone deformities, cartilage damage and synovitis. signs and symptoms include pain and tenderness of joints, morning stiffness for more than 30 minutes, fever, fatigue and weight loss . Also, there are extra-articular manifestations like rheumatoid nodules , interstitial lung disease and ocular manifestations like scleritis . Many treatment approaches in RA are based on anti- inflammatory, anti-oxidant and immune suppressive drugs mainly DMARDs. Up till now, there is no anti-inflammatory agent that is both safe and effective equivalent to DMARDs which are first line of treatment and that can be a scientific gap that should be filled in future research prespectives.
L-Carnitine is a nutritional supplement that is used for enhancing performance in
exercises, valproic acid toxicity, Rett syndrome and in case of secondary carnitine deficiency like in end stage renal disease (ESRD). Physiologically, it is synthesized from lysine and methionine. It is involved in energy production by assisting in transportation of long chain fatty acid into the mitochondria where they undergo beta oxidation for ATP production. Several studies have successfully proven that it has antioxidant effect by activating PPAR gamma which is transcription factor that directly increases expression of antioxidant enzymes like super oxide dismutase (SOD) . LC also have anti-inflammatory effect by acting on PPAR gamma that also inhibits Nf-KB pathway, thus decreasing release of inflammatory mediators. That was mentioned in literature done on inflammatory diseases like coronary artery disease and sepsis . The need for an add on therapy in RA increases to improve response to treatment and provide cost effectiveness benefit that opens the door for repurposing trials.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Carnitine, Disease-modifying anti-rheumatic drugs
- Keywords
- Rheumatoid Arthritis, Carnitine, anti-inflammatory, anti-oxidant, ACR50%, disease activity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarnitineDrug
It is a nutritional supplement with trade name " Carnitol®" in Egypt.
Disease-modifying anti-rheumatic drugsDrug
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®) .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Disease-modifying anti-rheumatic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: From enrollment to the end of trial at 12 weeks
Secondary outcomes (6)
proportion of patients achieving ACR50% in both arms
It is a score used to measure disease activity in RA patients. ACR 50% is achieved when patient have 50% improvement in tender and swollen joints count and three out of the following five : ESR level , patient assessment of disease activity ( using visual analogue scale from 0 to 10) , physician assessment of disease activity ( using visual analogue scale from 0 to 10) , pain assessment ( using visual analogue scale from 0 to 10) and health assessment questionnaire . this outcome will be assessed at end of trial.
Measured: From enrollment to the end of trial at 12 weeks
change in HAQ DI for both arms
HAQ DI stands for health assessment questionnaire disability index that is used to reflect quality of life and functional disability where scores will vary from 0 to 3 and higher scores indicate more disability .
A validated Arabic copy will be used and measured both at baseline and at end of trial.
Measured: From enrollment to the end of trial at 12 weeks
change in TNF aplha for both arms
anti inflammatory marker
Measured: From enrollment to the end of trial at 12 weeks
change in MDA for both arms
It is an oxidative stress marker where higher values indicates more oxidative stress
Measured: From enrollment to the end of trial at 12 weeks
change in TAC for both arms
It is an oxidative stress marker where higher values indicate better anti oxidant effect .
Measured: From enrollment to the end of trial at 12 weeks
safety data for both arms
A list of drug related adverse events will be reviewed by patients at each follow up visit ( at end of each month ) and at end of study. It will be expressed as nominal data ( number of patients experienced a certain adverse event versus number of those who don't) .
Measured: From enrollment to the end of trial at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start31 Dec 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German University in Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753565
- Sponsor's protocol ID
- RACAR
- Status last verified
- Jan 2025
- First submitted
- 26 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 7362664Smolen 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.
PubMed 31969328Yamanaka 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.
PubMed 31475852Jiang 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.
PubMed 26647854Kiziltunc 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.
PubMed 9855215Conforti 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.
PubMed 33346115Bongartz 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.
PubMed 20155830Sayah 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.
PubMed 16021111Smolen 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.
PubMed 27156434Klareskog 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.
PubMed 32176395Crowson 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.
PubMed 21360492
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-carnitine Supplementation on Disease Activity in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT06753565
- Acronym / sponsor ID
- RACAR
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, Carnitine, anti-inflammatory, anti-oxidant, ACR50%, disease activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- German University in CairoUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients.
Detailed description
Rheumatoid arthritis (RA) is an inflammatory autoimmune disease that affects joints of hand, wrist and foot. Its epidemiology is more pronounced in female to male in ratio 3:1 . Etiology of the disease is related to genetics and environmental factors that lead to formation of epitopes initiating autoimmune response . It is characterized by symmetrical polyarthritis in equal or more than 5 joints and it is known that long term inflammation leads to bone deformities, cartilage damage and synovitis. signs and symptoms include pain and tenderness of joints, morning stiffness for more than 30 minutes, fever, fatigue and weight loss . Also, there are extra-articular manifestations like rheumatoid nodules , interstitial lung disease and ocular manifestations like scleritis . Many treatment approaches in RA are based on anti- inflammatory, anti-oxidant and immune suppressive drugs mainly DMARDs. Up till now, there is no anti-inflammatory agent that is both safe and effective equivalent to DMARDs which are first line of treatment and that can be a scientific gap that should be filled in future research prespectives.
L-Carnitine is a nutritional supplement that is used for enhancing performance in
exercises, valproic acid toxicity, Rett syndrome and in case of secondary carnitine deficiency like in end stage renal disease (ESRD). Physiologically, it is synthesized from lysine and methionine. It is involved in energy production by assisting in transportation of long chain fatty acid into the mitochondria where they undergo beta oxidation for ATP production. Several studies have successfully proven that it has antioxidant effect by activating PPAR gamma which is transcription factor that directly increases expression of antioxidant enzymes like super oxide dismutase (SOD) . LC also have anti-inflammatory effect by acting on PPAR gamma that also inhibits Nf-KB pathway, thus decreasing release of inflammatory mediators. That was mentioned in literature done on inflammatory diseases like coronary artery disease and sepsis . The need for an add on therapy in RA increases to improve response to treatment and provide cost effectiveness benefit that opens the door for repurposing trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| l-carnitine and conventional DMARDs | Experimental | Drug: Carnitine, Drug: Disease-modifying anti-rheumatic drugsl-carnitine 500 mg ( carnitine tartrate 500 mg) two capsules twice daily for three months as add on therapy to conventional DMARDs. |
| placebo and conventional DMARDs | Placebo comparator | Drug: Disease-modifying anti-rheumatic drugsplacebo 500 mg two capsules twice daily for three months as add on therapy to conventional DMARDs. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| CarnitineIt is a nutritional supplement with trade name " Carnitol®" in Egypt. | Drug | l-carnitine and conventional DMARDs |
| Disease-modifying anti-rheumatic drugsThey are immunosuppressive drugs used to improve disease activity in Rheumatoid Arthritis patients . Conventional DMARDs include methotrexate (Imutrexate®) , leflunomide(Arthfree®) , hydroxychloroquine (plaquenil®) and sulfasalazine(colosalazine®) . | Drug | l-carnitine and conventional DMARDs, placebo and conventional DMARDs |
Primary outcome
change in DAS28 ESR for both arms
Time frame: From enrollment to the end of trial at 12 weeks
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 .
6 secondary outcomes
proportion of patients achieving ACR50% in both arms
Time frame: From enrollment to the end of trial at 12 weeks
change in HAQ DI for both arms
Time frame: From enrollment to the end of trial at 12 weeks
change in TNF aplha for both arms
Time frame: From enrollment to the end of trial at 12 weeks
change in MDA for both arms
Time frame: From enrollment to the end of trial at 12 weeks
change in TAC for both arms
Time frame: From enrollment to the end of trial at 12 weeks
safety data for both arms
Time frame: From enrollment to the end of trial at 12 weeks
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 7 Jan 2025.
- Background: PubMed 7362664Fries 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.
- Background: PubMed 31969328Smolen 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.
- Background: PubMed 31475852Yamanaka 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.
- Background: PubMed 26647854Jiang 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.
- Background: PubMed 9855215Kiziltunc 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.
- Background: PubMed 33346115Conforti 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.
- Background: PubMed 20155830Bongartz 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.
- Background: PubMed 16021111Sayah 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.
- Background: PubMed 27156434Smolen 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.
- Background: PubMed 32176395Klareskog 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.
- Background: PubMed 21360492Crowson 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rheumatoid Arthritis (RA)
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
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Recruiting
GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection
Rheumatoid Arthritis
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
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 Phase 2 study testing Carnitine and Disease-modifying anti-rheumatic drugs in people with Rheumatoid Arthritis (RA), run by German University in Cairo 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 5 inclusion and 6 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 7 Jan 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mariam Ehab, Master (+2001223360548, mariam.ehab-azmy@guc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in DAS28 ESR for both arms (time frame: From enrollment to the end of trial at 12 weeks). 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 NCT06753565, which also lists 11 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 7 Jan 2025.