Crohn's DiseaseNCT00524537
A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott).
Trial summary
The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 5,025 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with Crohn's disease who have been prescribed adalimumab according to the local label.
Who may be able to join
- Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbvie sponsored investigational Crohn's disease (CD) trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
- Subjects who were participants in AbbVie sponsored investigational Crohn's CD trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
- Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
- Subjects willing to consent to data being collected and provided to AbbVie.
- Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.
Who cannot join
- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
About this study
Official title: A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab (Humira) Treatment | Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
For more details on adverse events please see the AE section below.
Measured: Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Secondary outcomes (10)
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" and at least one admission to hospital at given timepoint..
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" at given timepoint.
Measured: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524537
- Sponsor's protocol ID
- P06-134
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2007
- Last updated
- 24 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ahuja D, Luo J, Qi Y, Syal G, Boland BS, Chang J, Ma C, Jairath V, Xu R, Singh S. Impact of Treatment Response on Risk of Serious Infections in Patients With Crohn's Disease: Secondary Analysis of the PYRAMID Registry. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1286-1294.e4. doi: 10.1016/j.cgh.2024.01.003. Epub 2024 Jan 11.
PubMed 38216022D'Haens G, Reinisch W, Panaccione R, Satsangi J, Petersson J, Bereswill M, Arikan D, Perotti E, Robinson AM, Kalabic J, Alperovich G, Thakkar R, Loftus EV. Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn's Disease With up to 6 Years of Follow-Up in the Pyramid Registry. Am J Gastroenterol. 2018 Jun;113(6):872-882. doi: 10.1038/s41395-018-0098-4. Epub 2018 Jun 5.
PubMed 29867173
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
- ClinicalTrials.gov ID
- NCT00524537
- Acronym / sponsor ID
- P06-134
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,025 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 24 Jan 2017
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 Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab (Humira) Treatment | – | –Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn's disease who have been prescribed adalimumab according to the local label.
Key inclusion criteria (5 listed)
- Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbvie sponsored investigational Crohn's disease (CD) trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
- Subjects who were participants in AbbVie sponsored investigational Crohn's CD trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
- Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
- Subjects willing to consent to data being collected and provided to AbbVie.
- Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.
Key exclusion criteria (1 listed)
- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
Time frame: Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below.
10 secondary outcomes
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38216022Ahuja D, Luo J, Qi Y, Syal G, Boland BS, Chang J, Ma C, Jairath V, Xu R, Singh S. Impact of Treatment Response on Risk of Serious Infections in Patients With Crohn's Disease: Secondary Analysis of the PYRAMID Registry. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1286-1294.e4. doi: 10.1016/j.cgh.2024.01.003. Epub 2024 Jan 11.
- Derived from this study: PubMed 29867173D'Haens G, Reinisch W, Panaccione R, Satsangi J, Petersson J, Bereswill M, Arikan D, Perotti E, Robinson AM, Kalabic J, Alperovich G, Thakkar R, Loftus EV. Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn's Disease With up to 6 Years of Follow-Up in the Pyramid Registry. Am J Gastroenterol. 2018 Jun;113(6):872-882. doi: 10.1038/s41395-018-0098-4. Epub 2018 Jun 5.
- Related InfoLink provided by the sponsor.
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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.
AbbVie Inc study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott).
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 1 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs) (time frame: Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 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 NCT00524537, which also lists 2 linked publications.
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 24 Jan 2017.