Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) 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: 4,107 participants
Where: No sites listed yet
Study dates: May 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: Study population consisted of participants with Crohn's Disease (CD) who were treated with adalimumab.

Who may be able to join

Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

Who cannot join

Hypersensitivity against the drug or one of the other ingredients.

About this study

Official title: Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA® (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice

The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

Read the detailed description

This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Conditions: Crohn's Disease
Keywords: Routine clinical setting, Long-term efficacy and safety, Crohn's Disease, Humira®, Adalimumab
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 groups in NCT01083680
Study group	Role	What they receive
Participants with Crohn's Disease (CD)		Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit
The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.
Measured: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time
The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.
Measured: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.
Measured: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
For more details on adverse events please see the AE section below.
Measured: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Secondary outcomes (2)

4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time
The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores < 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.
Measured: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Compliance With the Self-injection Via the Humira®-PEN
Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.
Measured: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Dec 2015

First posted10 Mar 2010 (estimated)
Study startMay 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.
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: 4,107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083680
Sponsor's protocol ID: P10-278
Status last verified: Mar 2017
First submitted: 26 Feb 2010
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA® (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice
ClinicalTrials.gov ID: NCT01083680
Acronym / sponsor ID: P10-278
Conditions: Crohn's Disease
Keywords: Routine clinical setting, Long-term efficacy and safety, Crohn's Disease, Humira®, Adalimumab
Study type: Observational
Recruitment status: Completed
Enrolment: 4,107 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 4 Apr 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 study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants with Crohn's Disease (CD)	–	–Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Study population consisted of participants with Crohn's Disease (CD) who were treated with adalimumab.

Key inclusion criteria (1 listed)

Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

Key exclusion criteria (1 listed)

Hypersensitivity against the drug or one of the other ingredients.

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

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit
Time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants
Time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.
Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. For more details on adverse events please see the AE section below.

2 secondary outcomes

4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Compliance With the Self-injection Via the Humira®-PEN
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Crohn's Disease (CD)	4,107	263

Primary outcome: Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit

Time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60. Mean (Standard Deviation). Unit: units on a scale

Measure	Participants With Crohn's Disease (CD) n = 1168
Month 3	-117 (117)
Month 6	-124 (127)
Month 9	-131 (122)
Month 12	-137 (125)
Month 18	-142 (126)
Month 24	-137 (135)
Month 30	-145 (119)
Month 36	-149 (118)

Population analysed: Effectiveness analyses included all participants with evaluable data.

Primary outcome: Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time

Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60. Number. Unit: percentage of participants

Measure	Participants With Crohn's Disease (CD) n = 1471
Month 0 (Remission)	12.2
Month 0 (Mild disease)	28.8
Month 0 (Moderate disease)	54.2
Month 0 (Severe disease)	4.8
Month 3 (Remission)	64.4
Month 3 (Mild disease)	17.4
Month 3 (Moderate Disease)	17.2
Month 3 (Severe Disease)	1.0

Population analysed: Effectiveness analyses included all participants with evaluable data.

Primary outcome: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants

Time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60. Mean (Standard Deviation). Unit: units on a scale

Measure	Participants With Crohn's Disease (CD) n = 947
Month 3	10.8 (12.4)
Month 6	12.1 (13.2)
Month 9	12.6 (13.3)
Month 12	13.7 (13.8)
Month 18	13.2 (12.9)
Month 24	14.7 (14.6)
Month 30	14.8 (14.3)
Month 36	14.6 (14.8)

Population analysed: Effectiveness analyses included all participants with evaluable data.

Primary outcome: Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)

Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60. Number. Unit: percentage of participants

Measure	Participants With Crohn's Disease (CD) n = 4107
Value	16.7

Population analysed: Analysis included safety analysis population with incidence of greater than 1% during the study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Crohn's Disease (CD)	548 of 4,107 (13.3%)	0 of 4,107 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Crohn's Disease

RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
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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.

Sandra Bloch, MD study director

AbbVie Deutschland GmbH & Co. KG, Medical Department

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 1 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 4 Apr 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 4 Apr 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?

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit (time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60). The study lists 4 primary outcomes in all. 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 NCT01083680.

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 4 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.