Crohn's DiseasePROGNOSNCT02193048
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
An observational study of Crohn's Disease, run by Ferring Pharmaceuticals at 1 site in Germany.
Trial summary
The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- This study will evaluate a new clinical scoring system in patients receiving routine treatment
- How many people
- 216 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Specialist gastroenterological centres
Who may be able to join
- All patients with Crohn's disease who
- have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and
- are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal indications) and
- have consented to the documentation of their patient data and
- agree to the up to 5-year documentation of the course of disease
Who cannot join
- Pre-treatment with 5-ASA > 10 days
- Treatment with steroids > 10 days
- Treatment with antibiotics, immunosuppressants or biological agents > 10 days
Trial locations and contacts
1 site in 1 country.
Germany1 site
Investigational site (there may be other sites in this country)
Altenholz
About this study
The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- This study will evaluate a new clinical scoring system in patients receiving routine treatment
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study will evaluate a new clinical scoring system in patients receiving routine treatmentOther
Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.
| Study group | Role | What they receive |
|---|---|---|
| Patients newly diagnosed with Crohn's disease | This study will evaluate a new clinical scoring system in patients receiving routine treatment Receives: Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a Crohn's scoring system
Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193048
- Sponsor's protocol ID
- 000150
- Acronym
- PROGNOS
- Status last verified
- Apr 2024
- First submitted
- 16 Jul 2014
- Last updated
- 2 May 2024
- Results posted
- No
Publications
Kruis W, Bokemeyer B, Jessen P, Hoesl M, Mross M, Morgenstern J, Reimers B, Muller-Grage N, Leifeld L. Prospective Evaluation of the Prediction Score for a Mild Course of Crohn's Disease (PreMiCC) in Newly Diagnosed Patients With Crohn's Disease: The PROGNOS Study. Inflamm Bowel Dis. 2025 Mar 3;31(3):677-685. doi: 10.1093/ibd/izae086.
PubMed 38648264
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02193048
- Acronym / sponsor ID
- PROGNOS / 000150
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients newly diagnosed with Crohn's disease | – | Other: This study will evaluate a new clinical scoring system in patients receiving routine treatmentThis study will evaluate a new clinical scoring system in patients receiving routine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specialist gastroenterological centres
Key inclusion criteria (5 listed)
- All patients with Crohn's disease who
- have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and
- are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal indications) and
- have consented to the documentation of their patient data and
- agree to the up to 5-year documentation of the course of disease
Key exclusion criteria (3 listed)
- Pre-treatment with 5-ASA > 10 days
- Treatment with steroids > 10 days
- Treatment with antibiotics, immunosuppressants or biological agents > 10 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study will evaluate a new clinical scoring system in patients receiving routine treatmentTreatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs. | Other | Patients newly diagnosed with Crohn's disease |
Primary outcome
Evaluation of a Crohn's scoring system
Time frame: Up to 5 years
Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Results publication: PubMed 38648264Kruis W, Bokemeyer B, Jessen P, Hoesl M, Mross M, Morgenstern J, Reimers B, Muller-Grage N, Leifeld L. Prospective Evaluation of the Prediction Score for a Mild Course of Crohn's Disease (PreMiCC) in Newly Diagnosed Patients With Crohn's Disease: The PROGNOS Study. Inflamm Bowel Dis. 2025 Mar 3;31(3):677-685. doi: 10.1093/ibd/izae086.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Ferring Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a Crohn's scoring system (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.