Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis

Sponsor
Assiut University
Study ID
NCT07793786
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

First listed
Aug 31, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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.

Primary Outcome Measure

Presence of Subclinical Hypothyroidism [ Time Frame: Baseline ]

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