Colchicine for Autoimmune and Subacute Thyroiditis

NCT07571681 | Recruiting Phase 2

• 2 other identifiers: MU-THY-COL-2026-01MD-MU-IRB-R.24.11.2879
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Hashimoto Thyroiditis; Subacute Thyroiditis; Thyroiditis

Keywords

Colchicine; Prednisolone; Autoimmune Thyroiditis; Inflammation; C-reactive protein; ESR; Thyroid Pain; Randomized Trial

Outcome Measures

Primary Outcomes (3)

• Mean Change in C-Reactive Protein (CRP)

  Reduction in serum C-reactive protein concentration compared with baseline among treatment groups.

  Baseline, Month 3, Month 6

• Mean Change in Erythrocyte Sedimentation Rate (ESR)

  Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups.

  Baseline, Month 3, Month 6

• Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline

  Improvement in thyroid pain, neck tenderness, local discomfort, and inflammatory symptoms will be assessed using a standardized Thyroid Pain and Inflammatory Symptom Score ranging from 0 to 10, where higher scores indicate greater symptom severity and lower scores indicate clinical improvement.

  Baseline, Month 1, Month 3, Month 6

Secondary Outcomes (7)

• Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline

  Baseline, Month 3, Month 6

• Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline

  Baseline, Month 3, Month 6

• Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline

  Baseline, Month 6

• Change in Thyroid Ultrasound Inflammatory Findings from Baseline

  Baseline, Month 6

• Recurrence Rate of Thyroiditis

  Any recurrence during 6-month follow-up

Study Arms (3)

Colchicine

EXPERIMENTAL

Participants will receive oral colchicine 0.5 mg twice daily for 12 weeks. Dose reduction to 0.5 mg once daily will be permitted if gastrointestinal intolerance occurs.

Drug: colchicine

Prednisolone

ACTIVE COMPARATOR

Participants will receive oral prednisolone 20 mg daily for 14 days, followed by tapering by 5 mg every 1 to 2 weeks according to clinical response.

Drug: Prednisolone

Supportive Care

ACTIVE COMPARATOR

Participants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring.

Drug: NSAID

Interventions

NSAID DRUG

Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.

Supportive Care

colchicine DRUG

Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.

Colchicine

Prednisolone DRUG

Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.

Prednisolone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead
• Saudi German Hospital - Madinah: collaborator

Study Sites (2)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Saudi German Hospital

Jeddah, Mecca Region, 21461, Saudi Arabia

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Hashimoto Disease; Thyroiditis, Subacute; Thyroiditis; Thyroiditis, Autoimmune; Inflammation

Interventions

Colchicine; Prednisolone; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Amr A. El Sehrawy, MD, PhD, FRCPE

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

Central Study Contacts

Amr A. El Sehrawy, MD, PhD, FRCPE

CONTACT

+966503845019; amrsehrawy@mans.edu.eg

Amro A. Elbaz, MD

CONTACT

+201000191910; dramrbaz@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label trial. Participants, care providers, and investigators are aware of assigned interventions due to differences in treatment regimens.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1:1 ratio to colchicine, prednisolone, or supportive care. Study groups will be followed in parallel for 6 months to assess inflammatory, clinical, and thyroid function outcomes.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
• Access Criteria: Access to the data may be granted to qualified researchers for scientifically valid purposes after review and approval by the responsible institution and study investigators.

Locations

EG (1); SA (1)