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Completed

NCT Number: NCT00427921

Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Medical Information - Abbott

Abbott Park, Illinois, 60064, United States

About this study

This was a Phase 3, multicenter, open-label, Early Access Study with an induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 in subjects with moderately to severely active Crohn's Disease (CD) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. Failure of prior therapy was determined by the Investigator. Subjects were to have an 8-week wash-out period prior to Baseline from the last dose of infliximab.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females 18 years of age and older
  • Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion
  • Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; Crohn's Disease Activity Index score > 220 OR Harvey Bradshaw Index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX)
  • Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")

Exclusion criteria

  • History of cancer other than some skin and cervical cancers
  • History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
  • Subjects with other, poorly controlled medical conditions
  • Subjects with any prior exposure to Tysabri® (natalizumab)
  • Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer)
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study

Treatment and study plan

Adalimumab

Biological

160 mg loading dose, 80 mg at week 2, 40 mg every other week

Other names: ABT-D2E7, Humira

Primary outcomes

  1. Mean Extent of Exposure - Duration in Days

    Time frame: Up to 24 weeks

    Extent of exposure for all adalimumab treated subjects

  2. Total Number of Injections of Adalimumab

    Time frame: Up to 24 weeks

    Extent of exposure for all adalimumab treated subjects

  3. Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.

    Time frame: Up to 24 weeks

    Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).

Secondary outcomes

  1. Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).

    Time frame: Week 12, Week 24, and Last Assessment Value (last nonmissing value)

    Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.

  2. Overall Health Care Resource Utilization

    Time frame: Up to 24 weeks

    From the "Overall Health Care Resource Utilization Questionnaire": Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization.

  3. Employment Status: Number of Subjects Employed

    Time frame: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

    Summary of employment status of those employed.

  4. 50% Improvement in Draining Fistula Count and Fistula Healing

    Time frame: Week 12, Week 24, Last Assessment Value (last nonmissing value)

    Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent.

  5. Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment

    Time frame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

    Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity).

    Minimal clinically important difference = 7 points. Measure is Mean percent change.

  6. Hematology - Change From Baseline to Final Visit

    Time frame: Up to 24 weeks

    Changes from the Group mean at baseline are compared to the final visit Group mean value

  7. Clinical Chemistry - Change From Baseline to Final Visit

    Time frame: Up to 24 weeks

    Changes from the Group mean at Baseline are compared to the final visit Group mean value

  8. Urinalysis - Change From Baseline to Final Visit

    Time frame: Up to 24 weeks

    Changes from the Group mean at baseline are compared to the final visit Group mean value

  9. Work Productivity and Activity Impairment - Change From Baseline in Absenteeism

    Time frame: Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)

    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.

  10. Work Productivity and Activity Impairment - Change From Baseline in Presenteeism

    Time frame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.

  11. Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment

    Time frame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

Acronym: ACCESS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2007
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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