Optimization of the use of anti-TNF antibodies in Verneuil's disease: Interest of a systematic initial prescription of methotrexate

Optimization of the use of anti-TNF antibodies in Verneuil's disease: Interest of a systematic initial prescription of methotrexate - ADHAS

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002959-42-FR

Enrollment

180

Registered

2019-11-19

Start date

2020-01-20

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patient suffering from Verneuil's disease: Hurley II and III stages

Interventions

Trade Name: HUMIRA® Product Name: Humira® Pharmaceutical Form: Solution for injection Trade Name: IMETH® Product Name: IMETH®

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Female or male - Age >18 years - Diagnosis of Verneuil's disease: stages of Hurley II and III - No more than 20 abscesses or inflammatory nodules - Written informed consent - Patient affiliated or beneficiary of a social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Age < 18 years - Stage III or IV heart failure - Positive HIV serology - Hepatitis C or B positive serology - Latent tuberculosis (positive quantiferon) - Severe hepatic insufficiency - Previous treatments with adalimumab or infliximab. - Severe progressive hepatic disease - Cancer treatment under 5 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the clinical effect at 6 months of the anti-TNF (adalimumab) + methotrexate versus anti-TNF alone (adalimumab) combination in patients with Verneuil's disease.; Primary end point(s): The primary endpoint is the clinical response rate at Month 6, determined by Hidradenitis Suppurativa Clinical Response (HiSCR). ; Secondary Objective: - Evaluate the clinical effect of the anti-TNF (adalimumab) + methotrexate versus anti-TNF alone (adalimumab) combination with M1, M3 and M9. - Evaluate the circulating levels of adalimumab at M0, M3 and M6 - Evaluate the presence of ADA at M0, M3 and M6 - Find out a correlation between biological response and clinical response - Evaluating the adverse effects ; Timepoint(s) of evaluation of this end point: This score is validated and used in the trials to count the abscesses in Verneuil's disease and to evaluate the therapeutic results. The clinical response rate, determined by the HiSCR, is defined by: - A reduction of at least 50% compared to the initial evaluation of the total number of inflammatory abscesses and nodules - No increase in the number of abscesses or draining fistulas.	—

Measure

Time frame

Main Objective: Evaluate the clinical effect at 6 months of the anti-TNF (adalimumab) + methotrexate versus anti-TNF alone (adalimumab) combination in patients with Verneuil's disease.; Primary end point(s): The primary endpoint is the clinical response rate at Month 6, determined by Hidradenitis Suppurativa Clinical Response (HiSCR). ; Secondary Objective: - Evaluate the clinical effect of the anti-TNF (adalimumab) + methotrexate versus anti-TNF alone (adalimumab) combination with M1, M3 and M9. - Evaluate the circulating levels of adalimumab at M0, M3 and M6 - Evaluate the presence of ADA at M0, M3 and M6 - Find out a correlation between biological response and clinical response - Evaluating the adverse effects ; Timepoint(s) of evaluation of this end point: This score is validated and used in the trials to count the abscesses in Verneuil's disease and to evaluate the therapeutic results. The clinical response rate, determined by the HiSCR, is defined by: - A reduction of at least 50% compared to the initial evaluation of the total number of inflammatory abscesses and nodules - No increase in the number of abscesses or draining fistulas.

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Secondary

Measure	Time frame
Secondary end point(s): This score is validated and used in the trials to count the abscesses in Verneuil's disease and to evaluate the therapeutic results. The clinical response rate, determined by the HiSCR, is defined by: - A reduction of at least 50% compared to the initial evaluation of the total number of inflammatory abscesses and nodules - No increase in the number of abscesses or draining fistulas. ; Timepoint(s) of evaluation of this end point: - Clinical response rate at M1, M3 and M9, determined by the "HiSCR". - Circulating levels of adalimumab at M0, M3 and M6: plasma adalimumab assay (kits available). - Plasma levels are expected to collapse in the event of resistance - Appearance of blocking agents at M0, M3 and M6: blood test (kits available) - Correlation between biology and clinic: "HiSCR" score and plasma adalimumab - Adverse effects	—

Measure

Time frame

Secondary end point(s): This score is validated and used in the trials to count the abscesses in Verneuil's disease and to evaluate the therapeutic results. The clinical response rate, determined by the HiSCR, is defined by: - A reduction of at least 50% compared to the initial evaluation of the total number of inflammatory abscesses and nodules - No increase in the number of abscesses or draining fistulas. ; Timepoint(s) of evaluation of this end point: - Clinical response rate at M1, M3 and M9, determined by the "HiSCR". - Circulating levels of adalimumab at M0, M3 and M6: plasma adalimumab assay (kits available). - Plasma levels are expected to collapse in the event of resistance - Appearance of blocking agents at M0, M3 and M6: blood test (kits available) - Correlation between biology and clinic: "HiSCR" score and plasma adalimumab - Adverse effects

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Countries

France

Contacts

Public ContactProject Manager

ECTEN

mh.barba@ecten.eu330664888704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026