Rheumatoid ArthritisNCT07793786
Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Subclinical Hypothyroidism, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Subclinical Hypothyroidism, Thyroid Dysfunction
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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)
- History of thyroid surgery or radioactive iodine therapy
- Chronic kidney or liver disease
- Ongoing severe infections
- Malignancy
About this study
Official title: Prevalence of Subclinical Hypothyroidism in Patients of Rheumatoid Arthritis and Its Relation to Disease Activity
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).
- Keywords
- DAS28, Disease Activity, Thyroid Stimulating Hormone, Free Thyroxine, Autoimmune Thyroid Disease, Anti-CCP, Rheumatoid Factor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Patients | 75 adult patients (age ≥ 18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria, recruited from the Rheumatology Unit, Internal Medicine Department, Assiut University Hospitals. Participants will undergo clinical evaluation, disease activity assessment via DAS28 (TJC-28, SJC-28, ESR/CRP, and Patient Global Assessment), routine laboratory testing (CBC, liver/kidney functions, RF, anti-CCP), and thyroid profile analysis (serum TSH, FT4, FT3). | |
| Healthy Controls | 75 age- and sex-matched apparently healthy individuals recruited from hospital staff and companions of patients, with no history of joint disease or known thyroid disorder. Participants will undergo complete clinical evaluation, routine baseline laboratory investigations, and thyroid profile testing (serum TSH, FT4, FT3) for comparison with the case group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Wageh Azer Younan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793786
- Sponsor's protocol ID
- Subclinical Hypothyroid in RA
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subclinical Hypothyroidism in Patients of Rheumatoid Arthritis and Its Relation to Disease Activity
- ClinicalTrials.gov ID
- NCT07793786
- Acronym / sponsor ID
- Subclinical Hypothyroid in RA
- Keywords
- DAS28, Disease Activity, Thyroid Stimulating Hormone, Free Thyroxine, Autoimmune Thyroid Disease, Anti-CCP, Rheumatoid Factor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Aug 2026 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Patients | – | –75 adult patients (age ≥ 18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria, recruited from the Rheumatology Unit, Internal Medicine Department, Assiut University Hospitals. Participants will undergo clinical evaluation, disease activity assessment via DAS28 (TJC-28, SJC-28, ESR/CRP, and Patient Global Assessment), routine laboratory testing (CBC, liver/kidney functions, RF, anti-CCP), and thyroid profile analysis (serum TSH, FT4, FT3). |
| Healthy Controls | – | –75 age- and sex-matched apparently healthy individuals recruited from hospital staff and companions of patients, with no history of joint disease or known thyroid disorder. Participants will undergo complete clinical evaluation, routine baseline laboratory investigations, and thyroid profile testing (serum TSH, FT4, FT3) for comparison with the case group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
- History of thyroid surgery or radioactive iodine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Subclinical Hypothyroidism
Time frame: Baseline
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.
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 31 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Subclinical Hypothyroidism, run by Assiut University.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Subclinical Hypothyroidism (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.