Treat-to-target by Email During Urate-lowering Therapy in Gout

NCT04733079 | Active Not Recruiting

• 1 other identifier: APHP180167
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief Summary

Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance. In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results. The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.

Conditions

Gout; Inflammatory Rheumatism; Hyperuricemia; Posology Adjustment

Keywords

Treat-to-target; Gout; Tophus; Urate crystals; Urate-lowering therapy; Febuxostat; Allopurinol; Therapeutic strategy; Electronic messaging; Therapeutic compliance

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)

  Month 12

Secondary Outcomes (1)

• Average dose of ULT (allopurinol and febuxostat)

  Month 12

Study Arms (2)

E-mail follow-up group

EXPERIMENTAL

Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging

Other: Cleanweb electronic messaging ePro

Usual follow-up group

ACTIVE COMPARATOR

Adaptation and follow-up of ULT according to referring physician's habits

Other: Usual follow-up

Interventions

Cleanweb electronic messaging ePro OTHER

Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached

E-mail follow-up group

Usual follow-up OTHER

Adaptation and follow-up of ULT according to referring physician's habits

Usual follow-up group

Eligibility Criteria

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

You may qualify if:

• Adults aged over 18 years old
• Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or
• Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items:
• Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL \> 360 μmol/l during the crisis (3.5 pts)
• Patients without ULT or with an ineffective ULT defined by an SUL \> 360 μmol/l in intercritical pahse
• Patients who routinely use e-mail

You may not qualify if:

• Participating in another trial including the administration of a drug
• Patients treated with azathioprine
• Patients intolerant to hypouricemic treatments
• Unable to use the internet
• Difficulty understanding French
• Illiteracy
• Pregnant womenor breastfeeding mothers (see PHC article L.1121-5)
• Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6)
• Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8)
• Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hopital LARIBOISIERE - Rhumatologie

Paris, 75010, France

Location

Rhumathology department

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Gout; Rheumatic Fever; Hyperuricemia; Patient Compliance

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 1, 2021
• Study Start: December 15, 2021
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)