Inflammatory Bowel DiseaseHYRISSNCT05633771
Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
An observational study of Inflammatory Bowel Disease, run by Sandoz at 51 sites in 2 countries.
Trial summary
An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Hyrimoz
- How many people
- 562 participants
- Where
- 51 sitesin 2 countries
- Study dates
- 16 Feb 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for whom the investigator has decided to initiate treatment with Hyrimoz® in accordance with the approved SmPC and local clinical practice, will be eligible to participate in the study.
Who may be able to join
- Patients must meet all of the following criteria at Baseline:
- Patients initiating Hyrimoz® treatment.
- Patients with a confirmed diagnosis (following local recommendations) of one of these indications: CD or UC.
- Patients ≥ 18 years of age.
- Patient in whom the decision to initiate Hyrimoz® (naïve population) or to switch (switch population) from reference adalimumab to Hyrimoz® was accorded with his physician before the proposal to participate in the study.
- Patients meeting one of the following criteria:
Show all 10Show fewer
- Referred to as "switched patients": Patients treated continuously with adalimumab (other than Hyrimoz®) for at least 6 months, with an indication for continuing treatment with adalimumab at any therapeutic dose (physician's decision) and who have controlled stable disease for at least 3 months before study enrollment (according to the physician's criteria).
- Referred to as "biologic-naive patients": Patients who had an inadequate response or contraindications to conventional therapy with no exposure to any biological medicine and targeted therapies and started Hyrimoz® as a first-line biologic therapy according to the summary of product characteristics (SmPC).
- Patients able to complete and understand the self-administered questionnaires.
- Patients who have been informed and have provided a signed written consent as per local regulations prior to participation in the study
Who cannot join
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Patients enrolled in an ongoing interventional study.
- Patients with any contraindications to Hyrimoz® according to the SmPC.
- Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula).
- Use of any investigational drug in last 6 months prior to enrollment.
- Patient received any biological medicine or targeted therapy, in case of " biologic-naive patient ",
- Patient received adalimumab for less than 6 months or have controlled disease for less than 3 months, in case of "switched patient".
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
France38 sites
Sandoz Investigational Site France
Amiens
Sandoz Investigational Site France
Auxerre
Sandoz Investigational Site France
Bayonne
Sandoz Investigational Site France
Beauvais
Sandoz Investigational Site France
Brest
Sandoz Investigational Site France
Caen
Sandoz Investigational Site France
Castelnau-le-Lez
Sandoz Investigational Site France
Clermont-Ferrand
Sandoz Investigational Site France
Clichy
Sandoz Investigational Site France
Cornebarrieu
Sandoz Investigational Site France
Créteil
Sandoz Investigational Site France
Gien
Sandoz Investigational Site France
Le Coudray
Sandoz Investigational Site France
Le Kremlin-Bicêtre
Sandoz Investigational Site France
Lille
Sandoz Investigational Site France
Lyon
Sandoz Investigational Site France
Marseille
Sandoz Investigational Site France
Montpellier
Sandoz Investigational Site France
Nancy
Sandoz Investigational Site France
Neuilly-sur-Seine
Sandoz Investigational Site France
Nice
Sandoz Investigational Site France
Nîmes
Sandoz Investigational Site France
Orléans
Sandoz Investigational Site France
Paris
Sandoz Investigational Site France
Pessac
Sandoz Investigational Site France
Pierre-Bénite
Sandoz Investigational Site France
Poitiers
Sandoz Investigational Site France
Pringy
Sandoz Investigational Site France
Reims
Sandoz Investigational Site France
Rennes
Sandoz Investigational Site France
Saint-Etienne
Sandoz Investigational Site France
Saint-Nazaire
Sandoz Investigational Site France
Sarrebourg
Sandoz Investigational Site France
Toulouse
Sandoz Investigational Site France
Tours
Sandoz Investigational Site France
Troyes
Sandoz Investigational Site France
Vandœuvre-lès-Nancy
Sandoz Investigational Site France
Vénissieux
Belgium13 sites
Sandoz Investigational Site Belgium
Aalst
Sandoz Investigational Site Belgium
Antwerp
Sandoz Investigational Site Belgium
Bonheiden
Sandoz Investigational Site Belgium
Brussels
Sandoz Investigational Site Belgium
Eeklo
Sandoz Investigational Site Belgium
Ghent
Sandoz Investigational Site Belgium
Herentals
Sandoz Investigational Site Belgium
Kortrijk
Sandoz Investigational Site Belgium
Liège
Sandoz Investigational Site Belgium
Namur
Sandoz Investigational Site Belgium
Seraing
Sandoz Investigational Site Belgium
Sint-Niklaas
Sandoz Investigational Site Belgium
Tongeren
About this study
Official title: A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.
Read the detailed description
The main purpose of this non-interventional study is to assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation in Inflammatory Bowel Disease (IBD) patients.
Primary data will be collected at each data collection time point (visits will be according to local clinical practice). Data will be collected based on the information reported in the medical records. This study does not impose a therapy protocol, procedure or change in routine medical practice. Apart from self-administered questionnaires, no additional examinations or assessments are required, consequently there are no additional medical risks for the patients. The total duration of the study will be 36 months (3 years). The recruitment period will be for 2 years with individual patient follow-up for up to 1 year.
It is expected that patients will visit their physicians at regular intervals depending on local specific clinical practices. Four time points for data collection will be defined:
- T0 (patient inclusion in the study and Baseline characteristics).
- T1 (3-month follow-up ± 1 month).
- T2 (6-month follow-up and primary criteria -2/+3 months).
- T3 (12-month follow-up -3/+2 months).
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Hyrimoz
- Keywords
- Inflammatory Bowel Disease, IBD, NIS, HYRISS, adalimumab, Hyrimoz
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyrimozOther
Also called adalimumab biosimilar
There is no treatment allocation. Patients administered Hyrimoz by prescription that have started as routine medical treatment will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Hyrimoz | Patients prescribed with Hyrimoz Receives: Other: Hyrimoz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who remain on Hyrimoz® at 6 months after treatment initiation
Assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation
Measured: Up to 6 months
Secondary outcomes (9)
Percentage of patients who discontinue Hyrimoz
Percentage of patients who discontinue Hyrimoz® at T2 and T3 due to:
- Lack of efficacy.
- Intolerance/Adverse event(s) or special scenario.
- Patient's decision
- Nocebo effect
- Other reasons.
Measured: 6 months, 12 months
Percentage of patients with high level of treatment satisfaction using TSQM-9 questionnaire
To assess patients' treatment satisfaction (based on 9-item Treatment Satisfaction Questionnaire for Medication [TSQM 9], the percentage of patients with high level of treatment satisfaction (score ≥ 39) will be collected.
The TSQM-9 is declined with 9 questions about patient treatment satisfaction. Each answer gives a number of points depending of the question and the answer. The final score is the sum of points in each question. This questionnaire score from 9 to 59 points. In HYRISS study, we estimate that patient with < 39 pts in TSQM-9 are considered with a low satisfaction for the medication (satisfaction under 60%).
Measured: 3 months, 6 months, 12 months
Percentage of patients with high level of treatment adherence using adapted CQR5 questionnaire
To assess adherence/compliance to treatment (based on 5 item Compliance Questionnaire for Rheumatology [CQR5] adapted for gastroenterologist), percentage of patients with high level of treatment adherence (score ≥ 15) using adapted CQR5 questionnaire will be collected.
The CQR5 is declined with 5 questions about patient compliance to the treatment. Each answer gives from 1 to 4 points depending of the answer. The final score is the sum of points in each question. This questionnaire score from 5 (very low compliance) to 20 points (very strong compliance).
Measured: Baseline, 3 months, 6 months, 12 months
Percentage of patients with the perception of a high level of disease activity using VAS scale
To assess the patient's reported disease activity, percentage of patients with the perception of a high level (score ≥ 6) of disease activity will be collected using visual analog scale [VAS].
This visual analogue scale (VAS) is an instrument designed to document the disease activity. Patients are asked to rate their disease activity on a visual analogue scale (VAS): How active has your disease been this week? From 0 (Not active at all) to 10 cm (Extremely active).
Measured: Baseline, 3 months, 6 months, 12 months
Percentage of patients with a good perception about biosimilars using VAS scale
To assess the patient's reported perception about biosimilars at the inclusion visit, percentage of patients with a good perception (score ≥ 6) about biosimilars using VAS scale will be measured.
This visual analogue scale (VAS) is an instrument designed to document the perception of the patient about biosimilar. Patients are asked to rate their perception of biosimilar medicine on a visual analogue scale (VAS): Are you confident in using biosimilar? From 0 (I have no confidence at all) to 10 cm (I have a great confidence).
Measured: Baseline
Percentage of patients in remission
Remission defined as Harvey-Bradshaw Index [HBI] ≤ 4 [for Crohn's Disease] or partial Mayo score ≤ 1 [for Ulcerative Colitis]
Measured: Baseline, 3 months, 6 months, 12 months
Crohn's disease activity measurement: Harvey Bradshaw Index [HBI]
Crohn's disease activity will be measured with HBI score. Score is interpreted:
<4: Remission 4-7: Mild disease 8-16: Moderate disease >16: Severe disease
Measured: Up to 12 months
Ulcerative colitis activity measurement: partial Mayo calculation score
Ulcerative colitis activity will be measured using partial Mayo calculation score. Score is interpreted: ≤ 1: Remission 2 - 4: Low activity disease 5 -6: Moderate disease 7 - 9: Severe disease
Measured: Up to 12 months
Pattern of Hyrimoz® utilization
Pattern of Hyrimoz® utilization to be collected
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start16 Feb 2023
- Primary completion15 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633771
- Sponsor's protocol ID
- CGP2017IC01
- Acronym
- HYRISS
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
- ClinicalTrials.gov ID
- NCT05633771
- Acronym / sponsor ID
- HYRISS / CGP2017IC01
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, IBD, NIS, HYRISS, adalimumab, Hyrimoz
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 562 participants (estimated)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2022 (actual)
- 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.
An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.
Detailed description
The main purpose of this non-interventional study is to assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation in Inflammatory Bowel Disease (IBD) patients.
Primary data will be collected at each data collection time point (visits will be according to local clinical practice). Data will be collected based on the information reported in the medical records. This study does not impose a therapy protocol, procedure or change in routine medical practice. Apart from self-administered questionnaires, no additional examinations or assessments are required, consequently there are no additional medical risks for the patients. The total duration of the study will be 36 months (3 years). The recruitment period will be for 2 years with individual patient follow-up for up to 1 year.
It is expected that patients will visit their physicians at regular intervals depending on local specific clinical practices. Four time points for data collection will be defined:
- T0 (patient inclusion in the study and Baseline characteristics).
- T1 (3-month follow-up ± 1 month).
- T2 (6-month follow-up and primary criteria -2/+3 months).
- T3 (12-month follow-up -3/+2 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyrimoz | – | Other: HyrimozPatients prescribed with Hyrimoz |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom the investigator has decided to initiate treatment with Hyrimoz® in accordance with the approved SmPC and local clinical practice, will be eligible to participate in the study.
Key inclusion criteria (10 listed)
- Patients initiating Hyrimoz® treatment.
- Patients with a confirmed diagnosis (following local recommendations) of one of these indications: CD or UC.
- Patients ≥ 18 years of age.
- Patient in whom the decision to initiate Hyrimoz® (naïve population) or to switch (switch population) from reference adalimumab to Hyrimoz® was accorded with his physician before the proposal to participate in the study.
- Patients meeting one of the following criteria:
Key exclusion criteria (7 listed)
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Patients enrolled in an ongoing interventional study.
- Patients with any contraindications to Hyrimoz® according to the SmPC.
- Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula).
- Use of any investigational drug in last 6 months prior to enrollment.
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 |
|---|---|---|
| HyrimozAlso: adalimumab biosimilarThere is no treatment allocation. Patients administered Hyrimoz by prescription that have started as routine medical treatment will be enrolled. | Other | Hyrimoz |
Primary outcome
Percentage of patients who remain on Hyrimoz® at 6 months after treatment initiation
Time frame: Up to 6 months
Assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation
9 secondary outcomes
Percentage of patients who discontinue Hyrimoz
Time frame: 6 months, 12 months
Percentage of patients with high level of treatment satisfaction using TSQM-9 questionnaire
Time frame: 3 months, 6 months, 12 months
Percentage of patients with high level of treatment adherence using adapted CQR5 questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months
Percentage of patients with the perception of a high level of disease activity using VAS scale
Time frame: Baseline, 3 months, 6 months, 12 months
Percentage of patients with a good perception about biosimilars using VAS scale
Time frame: Baseline
Percentage of patients in remission
Time frame: Baseline, 3 months, 6 months, 12 months
Crohn's disease activity measurement: Harvey Bradshaw Index [HBI]
Time frame: Up to 12 months
Ulcerative colitis activity measurement: partial Mayo calculation score
Time frame: Up to 12 months
Pattern of Hyrimoz® utilization
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Sandoz at 51 sites in 2 countries.
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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in France, Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of patients who remain on Hyrimoz® at 6 months after treatment initiation (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.