Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

NCT00573794 | Completed Phase 3 Results

• 2 other identifiers: M10-2232007-004157-28
• Study Type: interventional
• Target: 592
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Partial Mayo Score: Change From Baseline 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.

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

• Mayo Score: Change From Baseline Over Time

  The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 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.

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Secondary Outcomes (23)

• Percentage of Participants With Remission Per Partial Mayo Score Over Time

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

• Mayo Endoscopy Subscore: Change From Baseline Over Time

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

• Mayo Rectal Bleeding Subscore: Change From Baseline Over Time

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

• Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

• Mayo Stool Frequency Subscore: Change From Baseline Over Time

  Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Study Arms (1)

Adalimumab 40 mg EOW/EW

EXPERIMENTAL

Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

adalimumab prefilled syringes administered as subcutaneous injection EW or EOW

Also known as: ABT-D2E7, HUMIRA

Adalimumab 40 mg EOW/EW

Eligibility Criteria

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

You may qualify if:

• Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
• Subject is judged to be in generally good health as determined by the principal investigator

You may not qualify if:

• Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629)
• Subject considered by the investigator, for any reason, to be an unsuitable candidate
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (2)

• Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26.

  PMID: 25155227 BACKGROUND

• Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

  PMID: 29380251 DERIVED

Related Links

• Related Info.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Efficacy data after Week 292 should be interpreted with caution because less than 10% of subjects were under observation beyond Week 292.

Results Point of Contact

• Title: Global Medical Services
• 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: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: November 28, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 7, 2021
• Results First Posted: December 19, 2017

Record last verified: 2021-07