A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

NCT00524537 | Completed Results

• 1 other identifier: P06-134
• Study Type: observational
• Target: 5,025
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months

Study Arms (1)

Adalimumab (Humira) Treatment

Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease who have been prescribed adalimumab according to the local label.

You may qualify if:

• 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.

You may not qualify if:

• \- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (2)

• 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.

  PMID: 38216022 DERIVED

• D'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.

  PMID: 29867173 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• AbbVie Inc

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 24, 2017
• Results First Posted: January 24, 2017

Record last verified: 2017-01