Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Subclinical Hypothyroidism Thyroid Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prevalence of Subclinical Hypothyroidism in Patients of Rheumatoid Arthritis and Its Relation to Disease Activity

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 31, 2026
Registry last updated: Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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