Colchicine for Autoimmune and Subacute Thyroiditis

Официальное название

Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial

Обзор

Thyroiditis includes inflammatory thyroid disorders such as Hashimoto's thyroiditis and subacute thyroiditis. These conditions may cause thyroid pain, neck tenderness, elevated inflammatory markers, thyroid dysfunction, fatigue, and recurrence. Current management includes observation, symptomatic treatment, nonsteroidal anti-inflammatory drugs, and corticosteroids. Although corticosteroids may be effective, relapse after tapering and treatment-related adverse effects remain limitations. Colchicine is hypothesized to reduce inflammatory activity and may improve biochemical and clinical recovery. This study will evaluate the efficacy and safety of low-dose colchicine compared with corticosteroid therapy and supportive care in adults with autoimmune or subacute thyroiditis.

Подробное описание

Thyroiditis represents a heterogeneous group of inflammatory thyroid disorders. Hashimoto's thyroiditis is characterized by chronic autoimmune-mediated thyroid inflammation and progressive thyroid dysfunction. Subacute thyroiditis commonly presents with painful thyroid enlargement, elevated inflammatory markers, transient thyrotoxicosis, and possible later hypothyroidism.

Current treatment strategies include supportive care, nonsteroidal anti-inflammatory drugs, and corticosteroids. While corticosteroids often provide rapid symptomatic benefit, recurrence after withdrawal and steroid-related adverse effects remain clinically relevant concerns.

Colchicine inhibits microtubule polymerization, leukocyte migration, and inflammasome-mediated signaling. These mechanisms may provide potential benefit in thyroid inflammatory disease.

This prospective three-arm randomized controlled trial will compare colchicine, corticosteroid therapy, and supportive care regarding inflammatory improvement, thyroid function recovery, symptom control, recurrence, and tolerability.

Participants will be randomized in a 1:1:1 ratio and followed for six months. Primary outcomes include changes in C-reactive protein, erythrocyte sedimentation rate, and clinical symptom improvement. Secondary outcomes include thyroid function tests, thyroid autoantibodies, ultrasound improvement, recurrence rate, need for rescue corticosteroid therapy, and adverse events.

This study may help identify an effective steroid-sparing therapeutic strategy for inflammatory thyroid disorders.

Вмешательства

• Препарат colchicine
  Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.
• Препарат Prednisolone
  Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.
• Препарат NSAID
  Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.

Первичные конечные точки

• Mean Change in C-Reactive Protein (CRP) [Срок оценки: Baseline, Month 3, Month 6]
• Mean Change in Erythrocyte Sedimentation Rate (ESR) [Срок оценки: Baseline, Month 3, Month 6]
• Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline [Срок оценки: Baseline, Month 1, Month 3, Month 6]

Вторичные конечные точки (7)

• Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline [Срок оценки: Baseline, Month 3, Month 6]
• Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline [Срок оценки: Baseline, Month 3, Month 6]
• Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline [Срок оценки: Baseline, Month 6]
• Change in Thyroid Ultrasound Inflammatory Findings from Baseline [Срок оценки: Baseline, Month 6]
• Recurrence Rate of Thyroiditis [Срок оценки: Any recurrence during 6-month follow-up]
• Need for Rescue Corticosteroid Therapy [Срок оценки: Throughout 6-month follow-up]
• Adverse Events / Drug Intolerance [Срок оценки: Baseline to Month 6]

Критерии участия

Критерии включения

• Age 18 to 70 years
• Newly diagnosed Hashimoto's thyroiditis or Subacute thyroiditis
• Diagnosis confirmed clinically, biochemically, and ultrasonographically
• Ability to provide written informed consent

Критерии исключения

• Pregnancy or breastfeeding
• Severe renal impairment
• Severe hepatic disease
• Cytopenia
• Active serious infection
• Known hypersensitivity to colchicine
• Chronic corticosteroid use within previous 30 days
• Participation in another interventional trial
• Any condition affecting safety or protocol adherence

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Mansoura University — Al Mansurah

Саудовская Аравия · 1 центр

• Saudi German Hospital — Jeddah

Публикации

• Li Y, Hu Y, Zhang Y, Cheng K, Zhang C, Wang J. Advances in Subacute Thyroiditis: Pathogenesis, Diagnosis, and Therapies. FASEB J. 2025 Apr 15;39(7):e70525. doi: 10.1096/fj.202403264R. PMID 40203050
• Wang L, Zhu X, Xu S, Zhou B, Wu Y, Li Z, Zhao Y, Li S, Cheng F, Zhu L. Hashimoto's thyroiditis: from pathogenesis to clinical management. Front Endocrinol (Lausanne). 2026 Feb 2;17:1729316. doi: 10.3389/fendo.2026.1729316. eCollection 2026. PMID 41704486
• Wolowiec L, Osiak-Gwiazdowska J, Jasniak A, Mucha W, Wojtaluk M, Czerniecka W, Wolowiec A, Banach J, Grzesk G. Colchicine in Contemporary Pharmacotherapy: Mechanistic Insights and Clinical Horizons. J Clin Med. 2025 Oct 7;14(19):7078. doi: 10.3390/jcm14197078. PMID 41096157
• Bao RH, et al. Balancing the benefits and risks of colchicine use among patients with coronary heart disease. 2025. Colchicine exerts anti-inflammatory effects through inhibition of microtubule function, suppression of NLRP3 inflammasome activation, and reduction of hs-CRP.
• Plotz B, et al. New perspectives on the NLRP3 inflammasome: colchicine and suppression of inflammatory pathways in metabolic syndrome-associated diseases. Explor Musculoskeletal Dis. 2025;3:1007104.

Идентификаторы

NCT: NCT07571681 · MU-THY-COL-2026-01 · MD-MU-IRB-R.24.11.2879

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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