CoCroS trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universiteit Maastricht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

23 Dec 2019 → ongoing

Decision date (initial)

2024-12-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516002-33-01

EudraCT number

2017-004588-11

ClinicalTrials.gov

NCT03917303

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The aim of this study is to compare the long-term efficacy and safety of periodic adalimumab as initial treatment in newly diagnosed Crohn's disease (CD) patients compared to standard step-up care with corticosteroids/budesonide as the initial treatment.

Conditions and MedDRA coding

Crohn's disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres
2. CD diagnosis according to ECCO-guidelines + complete ileocolonoscopy (last endoscopy performed <12 months before screening) + complete small bowel imaging at diagnosis (MRI or CT-enterography)
3. Naïve to biologicals
4. 18 years old ≤ 70 years old
5. Sufficient knowledge of Dutch language
6. Smartphone with internet access
7. Use of myIBDcoach or willingness to start using myIBDcoach

Exclusion criteria 8

1. Use of prednisone for longer than 4 weeks in the year before screening
2. Use of thiopurines in the 3 years before screening
3. Indication for primary treatment with biologicals or surgery
4. Patients with short bowel syndrome or an ostomy
5. Malignancy in the 5 years before screening. Exception is adequately treated nonmelanoma skin cancer
6. Contra-indication for TNF-blockers or immunosuppressive agents (Contraindications are: a symptomatic stricture, an abscess, a history of tuberculosis or other granulomatous infection, a positive chest radiograph or Quantiferon or tuberculin skin test with purified protein derivative, a recent history of an opportunistic infection (within the previous 6 months), active infection with hepatitis B or C, infection with the human immunodeficiency virus, multiple sclerosis or cancer (except adequately treated non melanoma skin cancer))
7. Contra-indication for MRI- and CT-enterography
8. Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the difference in number of yearly-quarters of corticosteroid free clinical and biochemical remission at week 96. Safety outcomes are disease progression at week 96, drug related adverse events and disease related serious adverse events (hospitalisations, surgery).

Secondary endpoints 1

1. The secondary outcomes are total health care costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, drug-related side effects and patient reported outcome measures on quality of life, (work) disability and treatment-tolerability.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universiteit Maastricht

Sponsor organisation

Universiteit Maastricht

Address

P. O. Box 616

City

Maastricht

Postcode

6200 MD

Country

Netherlands

Scientific contact point

Organisation

Universiteit Maastricht

Contact name

NUTRIM

Public contact point

Organisation

Universiteit Maastricht

Contact name

NUTRIM

Locations

1 EU/EEA country · 1 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 4 files

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

Application history

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