## Protocol Section
### Identification Module
**NCT ID:** NCT04733079

**Acronym:** GOUTEmail

**Brief Title:** Treat-to-target by Email During Urate-lowering Therapy in Gout

**Official Title:** Treat-to-target by Email During Urate-lowering Therapy in Gout

#### Organization Study ID Info
**ID:** APHP18067
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-30

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-15

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2021-02-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-24
**Study First Submit QC Date:** 2021-01-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** The study will include 204 gouty patients without ULT or with ineffective ULT. This is a multicenter and randomized study (e-mail follow-up vs usual follow-up groups).

This study will include the following visits:

* Selection/inclusion visit (V0):

  * If available biological data (leucocyte count, hemoglobin level, creatininemia and estimated glomerular filtration rate (eGFR), SUL) were assessed during the last month, , included patient will be randomized at the end of the consultation to follow either an email-led T2T strategy or usual ULT care.
  * In the absence of biological results, the patient will be reviewed within the month with blood analysis and then randomized.
* Follow-up visits: consultations will be carried out according to the usual care of the referring physician.
* Visit M12 end of research: clinical evaluation of gout, demographic characteristics, medication, type and dose of ULT, blood analysis (serum creatinine level, eGFR, SUL).

The study ends after the M12 consultation. The total duration of participation in the study is 12 months.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 204

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Cleanweb electronic messaging ePro

**Label:** E-mail follow-up group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Usual follow-up

**Label:** Usual follow-up group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- E-mail follow-up group

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

**Name:** Cleanweb electronic messaging ePro

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Usual follow-up group

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

**Name:** Usual follow-up

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** Month 12

#### Secondary Outcomes

**Measure:** Average dose of ULT (allopurinol and febuxostat)

**Time Frame:** Month 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hang-korng.ea@aphp.fr

**Name:** Korng EA, PH-PU

**Phone:** 1 49 95 88 25

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Hang-Korng Pr EA, PHPU

- **Role:** CONTACT

**Country:** France

**Facility:** Rhumathology department

**State:** Ile-De-France

**Status:** RECRUITING

**Zip:** 75010

**Location 2:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** johann.beaudreuil@aphp.fr

- **Name:** Johann BEAUDREUIL, PUPH

- **Phone:** 01 49 95 88 28

- **Role:** CONTACT

**Country:** France

**Facility:** Hopital LARIBOISIERE - Rhumatologie

**Status:** RECRUITING

**Zip:** 75010

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000070657

- Term: Crystal Arthropathies

- ID: D000011686

- Term: Purine-Pyrimidine Metabolism, Inborn Errors

- ID: D000008661

- Term: Metabolism, Inborn Errors

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000013290

- Term: Streptococcal Infections

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC01

- Name: Infections

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: HIGH

- As Found: Rheumatism

- ID: M24343

- Name: Hyperuricemia

- Relevance: HIGH

- As Found: Hyperuricemia

- ID: M9177

- Name: Gout

- Relevance: HIGH

- As Found: Gout

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15042

- Name: Rheumatic Fever

- Relevance: HIGH

- As Found: Inflammatory Rheumatism

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M8464

- Name: Fever

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M630

- Name: Crystal Arthropathies

- Relevance: LOW

- As Found: Unknown

- ID: M11641

- Name: Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M14540

- Name: Purine-Pyrimidine Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16080

- Name: Streptococcal Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19252

- Name: Gram-Positive Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: T4999

- Name: Rheumatic Fever

- Relevance: HIGH

- As Found: Inflammatory Rheumatism

- ID: T163

- Name: Acute Articular Rheumatism

- Relevance: HIGH

- As Found: Inflammatory Rheumatism

### Condition Browse Module - Meshes

- ID: D000012213

- Term: Rheumatic Fever

- ID: D000006073

- Term: Gout

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000033461

- Term: Hyperuricemia

### Intervention Browse Module - Browse Branches

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M434

- Name: Febuxostat

- Relevance: LOW

- As Found: Unknown

- ID: M17277

- Name: Uric Acid

- Relevance: LOW

- As Found: Unknown

- ID: M3834

- Name: Allopurinol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
