Crohn's DiseasePhase 3ACCESSNCT00427921
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
A Phase 3 study testing adalimumab in people with Crohn's Disease, run by Abbott at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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")
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information - Abbott
Abbott Park, Illinois, 60064
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Crohn's Disease
- Being tested
- adalimumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7, Humira
160 mg loading dose, 80 mg at week 2, 40 mg every other week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open Label Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Extent of Exposure - Duration in Days
Extent of exposure for all adalimumab treated subjects
Measured: Up to 24 weeks
Total Number of Injections of Adalimumab
Extent of exposure for all adalimumab treated subjects
Measured: Up to 24 weeks
Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.
Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).
Measured: Up to 24 weeks
Secondary outcomes (11)
Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).
Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.
Measured: Week 12, Week 24, and Last Assessment Value (last nonmissing value)
Overall Health Care Resource Utilization
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.
Measured: Up to 24 weeks
Employment Status: Number of Subjects Employed
Summary of employment status of those employed.
Measured: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
50% Improvement in Draining Fistula Count and Fistula Healing
Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent.
Measured: Week 12, Week 24, Last Assessment Value (last nonmissing value)
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
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.
Measured: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Hematology - Change From Baseline to Final Visit
Changes from the Group mean at baseline are compared to the final visit Group mean value
Measured: Up to 24 weeks
Clinical Chemistry - Change From Baseline to Final Visit
Changes from the Group mean at Baseline are compared to the final visit Group mean value
Measured: Up to 24 weeks
Urinalysis - Change From Baseline to Final Visit
Changes from the Group mean at baseline are compared to the final visit Group mean value
Measured: Up to 24 weeks
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
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%.
Measured: Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
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%.
Measured: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
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%.
Measured: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
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 Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jimmy Baloukas, Study director, AbbottRemo Panaccione, MD, FRCPC, Study chair, Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427921
- Sponsor's protocol ID
- W06-405
- Acronym
- ACCESS
- Status last verified
- Nov 2009
- First submitted
- 26 Jan 2007
- Last updated
- 20 Nov 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00427921
- Acronym / sponsor ID
- ACCESS / W06-405
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 23 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: adalimumabOpen Label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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")
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humira160 mg loading dose, 80 mg at week 2, 40 mg every other week | Biological | 1 |
Primary outcome
Mean Extent of Exposure - Duration in Days
Time frame: Up to 24 weeks
Extent of exposure for all adalimumab treated subjects
Total Number of Injections of Adalimumab
Time frame: Up to 24 weeks
Extent of exposure for all adalimumab treated subjects
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).
11 secondary outcomes
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)
Overall Health Care Resource Utilization
Time frame: Up to 24 weeks
Employment Status: Number of Subjects Employed
Time frame: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
50% Improvement in Draining Fistula Count and Fistula Healing
Time frame: Week 12, Week 24, Last Assessment Value (last nonmissing value)
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)
Hematology - Change From Baseline to Final Visit
Time frame: Up to 24 weeks
Clinical Chemistry - Change From Baseline to Final Visit
Time frame: Up to 24 weeks
Urinalysis - Change From Baseline to Final Visit
Time frame: Up to 24 weeks
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- For more information, see attached websiteLink provided by the sponsor.
Related trials for Crohn's Disease
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.
Jimmy Baloukas study director
Abbott
Remo Panaccione, MD, FRCPC study chair
Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Crohn's Disease, run by Abbott at 1 site in United States.
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 4 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 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2009). 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?
Mean Extent of Exposure - Duration in Days (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2009.