Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder that causes persistent joint inflammation and damage. Thyroid disorders, particularly subclinical hypothyroidism, are common co-existing conditions in patients with autoimmune diseases. Subclinical hypothyroidism occurs when the thyroid gland is mildly underactive, characterized by an elevated thyroid-stimulating hormone (TSH) level with normal free thyroxine (FT4) levels.
The primary purpose of this cross-sectional study is to determine how common subclinical hypothyroidism is among Egyptian patients with rheumatoid arthritis compared to an age- and sex-matched group of healthy individuals. Additionally, the study aims to evaluate whether the presence of subclinical hypothyroidism is linked to higher rheumatoid arthritis disease activity, severe joint involvement, or specific clinical characteristics.
A total of 150 adult participants will be included: 75 patients diagnosed with rheumatoid arthritis and 75 healthy controls. All participants will undergo a clinical evaluation, joint examinations, and standard blood tests, including complete blood counts, inflammatory markers, and a thyroid hormone panel (TSH, FT4, and FT3). Disease activity in rheumatoid arthritis patients will be evaluated using the Disease Activity Score-28 (DAS28).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, either sex
Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria (for the case group)
Apparently healthy individuals with no history of joint disease or known thyroid disorder, matched for age and sex (for the control group)
Willingness to provide written informed consent
Disqualifiers
Known pre-existing thyroid disease diagnosed prior to rheumatoid arthritis onset
Current or recent (within 6 months) use of medications known to affect thyroid function (e.g., amiodarone, lithium, interferon)
Pregnancy or lactation
Other systemic autoimmune diseases that could independently affect thyroid function (e.g., systemic lupus erythematosus, overlap syndromes)
Trial population
Adult patients aged 18 years and older diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria attending the Rheumatology Unit, Internal Medicine Department, Assiut University Hospitals, as well as age- and sex-matched apparently healthy control individuals recruited from hospital staff and patient companions with no history of joint disease or thyroid disorders.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Rheumatoid Arthritis Patients
Group B: Healthy Controls
Trial outcomes
Primary outcomes
1
Presence of Subclinical Hypothyroidism
Presence of subclinical hypothyroidism assessed as a binary measure (yes/no), defined as an elevated serum thyroid-stimulating hormone (TSH) level with a concurrently normal free thyroxine (FT4) level based on standard laboratory reference ranges.
Time frame
BaselineLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: