Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis

NCT01494857 | Unknown Phase 3

• 2 other identifiers: KHK - AD001A13-675
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; biological treatment; anti-TNF

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with clinical response per Mayo Score, at Week 12

  week 12

Secondary Outcomes (1)

• Proportion of subjects with remission per Mayo Score at Week 12.

  week 12

Study Arms (1)

Adalimumab

EXPERIMENTAL

Adalimumab 40 mg

Drug: Adalimumab

Interventions

Adalimumab DRUG

Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.

Also known as: Brand name - Humira (Abbott Pharmaceuticals)

Adalimumab

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years of age.
• Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
• Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):
• Stable oral corticosteroid dose (prednisone dose of \>= 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisone of \< 20 mg/day) for at least 40 days prior to Baseline, and/or
• At least a consecutive 90 day course of azathioprine or 6-mercaptopurine (6 MP) prior to Baseline, with a dose of azathioprine \>= 1.5 mg/kg/day or 6 MP \>= 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Participant was to be on a stable dose for at least 28 days prior to Baseline.
• Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.
• Has to be able to self-administer subcutaneous injections or has caregiver who can reliably administer subcutaneous injections.
• Has to be able and willing to give written informed consent and to comply with the requirements of this study protocol.

You may not qualify if:

• History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery.
• Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
• Received cyclosporine, tacrolimus, or mycophenolate mofetil, within 30 days prior to Baseline.
• Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
• Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of Screening Period.
• Current diagnosis of fulminant colitis and/or toxic megacolon.
• Subject with disease limited to the rectum (ulcerative proctitis).
• Current diagnosis of indeterminate colitis.
• Current diagnosis and/or history of Crohn's disease.
• Currently receiving total parenteral nutrition (TPN).
• Subject using aminosalicylates for less than 90 days prior to Baseline or not on a stable dose for at least 28 days prior to Baseline or discontinued use within 28 days of Baseline.
• Subject with positive Clostridium difficile (C. difficile) stool assay.
• Subject who has previously used infliximab or any anti-TNF agent within 56 days of Baseline.
• Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded at any time ("primary non-responder") unless subject experienced a treatment limiting reaction.

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (3)

Sherutey Briuth Clalit / Clalit HMO

Herzlyia, Israel

NOT YET RECRUITING

Lev Talpiot Clinic, Clalit health Services

Jerusalem, Israel

RECRUITING

Zevulun Clinic, Clalit Health Services

Kiryat Bialik, Israel

RECRUITING

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

Central Study Contacts

Timna Naftali, MD

CONTACT

972-3-6923660; Timna.Naftali@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

IL (3)