Colchicine for Autoimmune and Subacute Thyroiditis (COLTHYR)

Mansoura University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Thyroiditis; Subacute Thyroiditis; Hashimoto Thyroiditis

Treatments: Drug: NSAID; Drug: Prednisolone; Drug: colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT07571681

MU-THY-COL-2026-01

MD-MU-IRB-R.24.11.2879 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Colchicine

Experimental group

Description:

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.

Treatment:

Drug: colchicine

Prednisolone

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisolone

Supportive Care

Active Comparator group

Description:

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

Treatment:

Drug: NSAID