Antiphospholipid (aPL)-PositiveMERITNCT07892651
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
An observational study of Antiphospholipid (aPL)-Positive and Rheumatic Arthritis, run by Axiom Bioregistry at 1 site in Jordan.
Trial summary
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including individuals with chronic medical conditions and healthy volunteers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease
- How many people
- 5,000 participants
- Where
- 1 siteJordan
- Study dates
- 18 Oct 2026to Oct 2029
- How long will I take part?
- 3 Months
- Phase
- Observational
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals of Middle Eastern, North African, or Levantine ancestry, including both participants with chronic conditions and healthy volunteers.
Who may be able to join
- Individuals of Middle Eastern, North African, or Levantine ancestry, as determined by participant self-report.
- Individuals aged 18 years or older with chronic medical conditions; a confirmed diagnosis or self-reported history of one or more chronic medical conditions, supported by medical record review where available.
- Individuals below 18 years of age with a relevant chronic condition, where pediatric enrollment is subject to applicable ethical approvals and the required parental or legally authorized representative permission and participant assent, as applicable.
- Healthy volunteers: Individuals aged 18 years or older without known chronic medical conditions relevant to the registry, based on participant self-report and investigator assessment.
- Willing and able to provide written informed consent before initiation of any study procedures or, for pediatric participants, participation will be subject to applicable written parental/legal guardian permission and assent procedures, as appropriate.
- Eligible and willing to undergo the applicable study procedures, including collection of relevant clinical information and biological samples.
Who cannot join
- Inability to obtain the required informed consent, parental or legally authorized representative permission, or participant assent, as applicable.
- Acute illness, including fever (≥38°C), active infection, or a clinically unstable condition at the time of enrollment that, in the opinion of the investigator, may compromise participant safety or interfere with study procedures. Enrollment may be deferred until the condition resolves or the participant is clinically stable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Biosenses
Amman
Rami General Manager, +962 79 5833305, rami@biosenseslabs.com
About this study
Official title: A Multicenter Observational Registry of Clinical, Biological, Immunological Profiles in Underrepresented MENA/Levant With Chronic Conditions and Healthy Volunteers
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including individuals with chronic medical conditions and healthy volunteers. The registry will collect standardized clinical and participant-reported data, along with biological samples, to support the investigation of disease patterns, health-related characteristics, and population-specific biological and immunological profiles in populations historically underrepresented in biomedical research. The resulting data and samples may support future research into disease-associated biomarkers and underlying biological mechanisms.
Read the detailed description
This is a multicenter, multi-purpose, observational registry designed to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry. The registry will include individuals with chronic medical conditions as well as healthy volunteers.
The registry will collect standardized clinical information, medical history, relevant participant-reported information, and biological samples to support a broad range of current and future research investigating health-related characteristics, disease patterns, and biological variation in populations historically underrepresented in biomedical research.
Participants with chronic medical conditions may include individuals with, but are not limited to, the following conditions:
- Cardiovascular diseases
- Metabolic conditions, including hyperlipidemia and type 2 diabetes mellitus
- Autoimmune diseases
- Chronic gastrointestinal diseases
- Dermatologic diseases, including atopic dermatitis and psoriasis
- Respiratory diseases, including asthma and chronic obstructive pulmonary disease
- Renal and urological disorders
- Cognitive and neurological disorders
- Other chronic medical conditions meeting the study's eligibility criteria Healthy volunteers may also participate.
Study procedures will include informed consent, eligibility assessment, collection of medical history and relevant clinical information, review of medical records where applicable, and collection of biological samples, as specified in the study protocol. Samples may include serum, plasma, peripheral blood mononuclear cells (PBMCs), and urine. The types of samples collected may vary among participants and participating sites.
This is an observational registry with no randomization. No investigational interventions or investigator-assigned treatments will be administered as part of the study. Participants' routine clinical care and treatment decisions will not be directed or modified by the registry.
The data and samples collected through the registry may support multiple future research projects addressing different scientific hypotheses across clinical, biological, and immunological domains. Research activities may include the investigation of disease-associated biomarkers and molecular or cellular characteristics, subject to participant consent.
- Conditions
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease, Focal Segmental Glomerulosclerosis (FSGS), Membranous Nephropathy, Crohn Disease (CD)
- Medical subject headings
- Rheumatic Fever, Celiac Disease, Glomerulosclerosis, Focal Segmental, Glomerulonephritis, Membranous, Crohn Disease, Diabetes Mellitus, Type 1, Nephritis, Hereditary, Glycogen Storage Disease Type II
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Enrolled Participants by Clinical Condition
Number and percentage of enrolled participants with each eligible chronic medical condition, including disease subtype where applicable. Healthy volunteers will be summarized separately from participants with chronic medical conditions.
Measured: At the enrollment/sample collection visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start18 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid (aPL)-PositiveStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Axiom Bioregistry
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892651
- Sponsor's protocol ID
- AXM-CHR-001
- Other IDs
- AXM Fund
- Acronym
- MERIT
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided