Ulcerative ColitisNCT01947816

Special Investigation in Patients With Ulcerative Colitis

An observational study of Ulcerative Colitis, run by AbbVie.

Completed

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

Trial summary

This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis. 1. Unknown adverse reactions (in particular, clinically significant) 2. Read more about this study

Who is it for?: Ages Up to 99 years
Conditions the study is for: Ulcerative Colitis
Type of treatment: Injection or infusion
How many people: 1,621 participants
Where: No sites listed yet
Study dates: 9 Aug 2013to 15 Feb 2018
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 Up to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients for the first time receiving Humira for the treatment of Ulcerative Colitis

Who may be able to join

Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

Who cannot join

Contraindications according to the Package Insert include patients who have any of the following:
serious infections
tuberculosis
a history of hypersensitivity to any ingredient of Humira
demyelinating disease or a history of demyelinating disease
congestive cardiac failure

About this study

Official title: HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis

This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.

Unknown adverse reactions (in particular, clinically significant)
Incidence and conditions of occurrence of adverse reactions in clinical practice
Factors likely to affect the safety and effectiveness

Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01947816
Study group	Role	What they receive
Humira		Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.

What is being measured

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

Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.
Measured: Up to Week 52

Secondary outcomes (4)

Change From Baseline in CRP Levels Over Time
Measured: Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)
Change From Baseline in Mayo Score Over Time
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Measured: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
Mayo Endoscopic Sub-Score Over Time
The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).
Measured: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
Change From Baseline in Partial Mayo Score Over Time
The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.
Measured: Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)

Timeline

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

9 Aug 201315 Feb 2018

First posted23 Sep 2013 (estimated)
Study start9 Aug 2013
Primary completion15 Feb 2018
Study completion15 Feb 2018

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 Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: 1,621 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01947816
Sponsor's protocol ID: P14-190
Status last verified: Nov 2018
First submitted: 18 Sep 2013
Last updated: 13 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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

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

All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis
ClinicalTrials.gov ID: NCT01947816
Acronym / sponsor ID: P14-190
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Study type: Observational
Recruitment status: Completed
Enrolment: 1,621 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 9 Aug 2013 (actual)
Primary completion: 15 Feb 2018 (actual)
Study completion: 15 Feb 2018 (actual)
First posted: 23 Sep 2013 (estimated)
Results: Posted 13 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.

Unknown adverse reactions (in particular, clinically significant)
Incidence and conditions of occurrence of adverse reactions in clinical practice
Factors likely to affect the safety and effectiveness

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Humira	–	–Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.

Who may qualify

Ages: Up to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients for the first time receiving Humira for the treatment of Ulcerative Colitis

Key inclusion criteria (1 listed)

Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

Key exclusion criteria (6 listed)

Contraindications according to the Package Insert include patients who have any of the following:
serious infections
tuberculosis
a history of hypersensitivity to any ingredient of Humira
demyelinating disease or a history of demyelinating disease

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 Adverse Drug Reactions and Serious Adverse Drug Reactions
Time frame: Up to Week 52
Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.

4 secondary outcomes

Change From Baseline in CRP Levels Over Time
Time frame: Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)
Change From Baseline in Mayo Score Over Time
Time frame: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
Mayo Endoscopic Sub-Score Over Time
Time frame: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
Change From Baseline in Partial Mayo Score Over Time
Time frame: Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)

Results and safety

Results posted to the registry on 13 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Humira	1,593	1,523

Primary outcome: Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions

Time frame: Up to Week 52. Count of participants. Unit: Participants

Measure	Humira n = 1523
Adverse Drug Reactions	276
Serious Adverse Drug Reactions	74

Population analysed: Safety Analysis Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Humira	74 of 1,523 (4.9%)	0 of 1,523 (0%)	5 of 1,523

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Ulcerative Colitis

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.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by AbbVie.

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 6 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 13 May 2019. 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 13 May 2019). 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 Adverse Drug Reactions and Serious Adverse Drug Reactions (time frame: Up to Week 52). 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 NCT01947816.

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 13 May 2019.