An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

14 Jan 2020 → ongoing

Decision date (initial)

2024-05-28

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Abbvie

External identifiers

EU CT number

2023-507256-76-00

EudraCT number

2018-003490-10

ClinicalTrials.gov

NCT04183608

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).

Conditions and MedDRA coding

Ulcerative colitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Adults with moderately-to-severely active Ulcerative Colitis (UC) who had an inadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine),methotrexate or vedolizumab or adults with moderately-to-severely active UC who had no response to an adequate steroid course
2. Age ≥ 18 years and < 75 years
3. Patients scheduled to start a treatment with adalimumab
4. Naïve to anti-TNF therapy and other biologics known to be effective for UC (approved or investigational) except for vedolizumab
5. Naïve to JAK inhibitors (approved or investigational)
6. Adults with moderately-to-severely active UC for at least 3 months with a Mayo score of 6-12 points (endoscopy subscore of at least 2)
7. Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed)
8. Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication
9. Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion.
10. A contraceptive method during the whole trial for childbearing potential female
11. Patient familiar with Smartphone and internet use

Exclusion criteria 13

1. People unable to give their consent (because of their physical or mental state).
2. Absence of written consent.
3. Pregnancy or breastfeeding.
4. Patients with severe acute colitis or patients at imminent risk for colectomy.
5. History of colectomy.
6. History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
7. Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.
8. Oral corticosteroids at a dose > 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion)
9. Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics (except vedolizumab),, JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first trial agent injection.
10. Contraindication to anti-TNF therapy including: Active infection ;Non-treated latent tuberculosis; Heart failure (NYHA: Grade III and IV) ;Malignancy during the previous 5 years; Demyelinating neurological disease; Current or recent (less than 4 weeks) vaccination with attenuated live vaccines
11. Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests
12. Patients using a prohibited medication
13. Patients participating in another trial or being in a follow-up period for another trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. At week 48 success defined by Endoscopic remission defined by an endoscopic Mayo score 0

Secondary endpoints 17

1. Clinical remission (Clinical remission is defined as a total Mayo score ≤ 2 points, with no individual sub score > 1, and a Mayo endoscopy sub score of 0 or 1)
2. Remission without steroids
3. Endoscopic healing rate with Mayo score 0 or 1
4. UCEIS score
5. Histological healing (Nancy score)
6. Remission rate and remission rate without steroids at study visits and W48
7. Quality of life evolution (evaluate visit 0 vs W14, W26, W38 and W48)
8. Patients satisfaction
9. Continuous response
10. Safety and tolerability
11. Anti-TNF pharmacokinetics
12. Number of visits in trial
13. Number of UC related hospitalizations
14. Number of colectomies
15. Treatment compliance (questionnaire)
16. Patient adhesion (questionnaire)
17. Medico-economic analysis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Sponsor organisation

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Address

50 Rue Richer

City

Paris

Postcode

75009

Country

France

Scientific contact point

Organisation

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Contact name

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Public contact point

Organisation

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Contact name

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Locations

1 EU/EEA country · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications