Comparison of azathioprine to methotrexate in combination therapy with adalimumab in Crohn’s Disease: an open-label randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002047-29-FR

Enrollment

166

Registered

2021-06-21

Start date

2021-07-29

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

crohn disease

Interventions

Trade Name: Humira Product Name: adalimumab Product Code: 02458357 Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female patients with age > 18 years - CD for at least 6 weeks, - Clinically active with CDAI > 150 - Active inflammation by endoscopy (as defined by CDEIS > 4) at baseline - Initiating treatment with adalimumab - Patient followed in a centre belonging to the GETAID network - Patient’s written consent 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66

Exclusion criteria

Exclusion criteria: - Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months) - Non-passable colonic stricture - Previous intolerance to thiopurines or MTX - Previous exposition to adalimumab - Contra-indication to adalimumab - Contra-indication to immunosuppressants or anti-TNF - Others serious simultaneous illness that could interfere with study participation - Planning pregnancy, pregnancy or lactation or absence of contraception - Known substance abusers - Use of any investigational drug within 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the endoscopic response to AZA and to MTX in combination with adalimumab in patients with CD;Secondary Objective: To compare AZA to MTX in combination therapy with adalimumab on clinical efficacy (remission and response) - To compare AZA to MTX in combination therapy with adalimumab in CD on the pharmacokinetics of adalimumab - To compare AZA to MTX in combination therapy with adalimumab on the level of inflammatory biomarkers - To compare the impact of AZA to MTX in combination therapy with adalimumab on CD-related disability - To compare the impact of AZA to MTX in combination therapy with adalimumab on CD-related quality of life - To compare the impact of AZA to MTX in combination therapy with adalimumab on CD natural history (surgeries and hospitalizations) - To compare the safety of AZA to MTX in combination therapy with adalimumab ;Primary end point(s): Endoscopic response defined as a decrease of at least 50% of the CDEIS at week W26 as compared to baseline. ;Timepoint(s) of evaluation of this end point: w26	—

Measure

Time frame

Main Objective: To compare the endoscopic response to AZA and to MTX in combination with adalimumab in patients with CD;Secondary Objective: To compare AZA to MTX in combination therapy with adalimumab on clinical efficacy (remission and response) - To compare AZA to MTX in combination therapy with adalimumab in CD on the pharmacokinetics of adalimumab - To compare AZA to MTX in combination therapy with adalimumab on the level of inflammatory biomarkers - To compare the impact of AZA to MTX in combination therapy with adalimumab on CD-related disability - To compare the impact of AZA to MTX in combination therapy with adalimumab on CD-related quality of life - To compare the impact of AZA to MTX in combination therapy with adalimumab on CD natural history (surgeries and hospitalizations) - To compare the safety of AZA to MTX in combination therapy with adalimumab ;Primary end point(s): Endoscopic response defined as a decrease of at least 50% of the CDEIS at week W26 as compared to baseline. ;Timepoint(s) of evaluation of this end point: w26

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Secondary

Measure	Time frame
Secondary end point(s): - Clinical remission and corticosteroid-free clinical remission (W12-W26) - Need for adalimumab optimization (W12-W26) - AZA, MTX and adalimumab withdrawal during follow-up - Trough serum levels of adalimumab (W12-W26) - Antibodies to adalimumab (ADA) (W12-W26) - Change in IBD-Q (quality of life index) from baseline to W26 - Change in IBD-DI (IBD disability index) from baseline to W26 - Change in CRP level from baseline to W12-W26 - Change in Calprotectin level from baseline to W12-W26 - Mucosal healing (no ulcers) at week 26 - Deep remission at week 26 (CDAI < 150 and no steroids and CRP < 5 and CDEIS < 4) - CD-related hospitalization during study period - CD-related surgery during study period - Occurrence of adverse events ;Timepoint(s) of evaluation of this end point: w26	—

Measure

Time frame

Secondary end point(s): - Clinical remission and corticosteroid-free clinical remission (W12-W26) - Need for adalimumab optimization (W12-W26) - AZA, MTX and adalimumab withdrawal during follow-up - Trough serum levels of adalimumab (W12-W26) - Antibodies to adalimumab (ADA) (W12-W26) - Change in IBD-Q (quality of life index) from baseline to W26 - Change in IBD-DI (IBD disability index) from baseline to W26 - Change in CRP level from baseline to W12-W26 - Change in Calprotectin level from baseline to W12-W26 - Mucosal healing (no ulcers) at week 26 - Deep remission at week 26 (CDAI < 150 and no steroids and CRP < 5 and CDEIS < 4) - CD-related hospitalization during study period - CD-related surgery during study period - Occurrence of adverse events ;Timepoint(s) of evaluation of this end point: w26

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Countries

France

Contacts

Public ContactAnnabelle Boussault

CHU Amiens Picardie

boussault.annabelle@chu-amiens.fr333220893698369

Outcome results

None listed

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