Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis

NCT07793786 | Not Yet Recruiting

• 1 other identifier: Subclinical Hypothyroid in RA
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Rheumatoid Arthritis; Subclinical Hypothyroidism; Thyroid Dysfunction

Keywords

DAS28; Disease Activity; Thyroid Stimulating Hormone; Free Thyroxine; Autoimmune Thyroid Disease; Anti-CCP; Rheumatoid Factor

Outcome Measures

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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal Medicine

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08