Crohn's DiseasePhase 3CLASSICIINCT01070303
Remission in Subjects With Crohn's Disease, Open Label Extension
A Phase 3 study testing Adalimumab 40 mg eow or ew in people with Crohn's Disease, run by Abbott at 43 sites in United States.
Trial summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Adalimumab 40 mg eow or ew
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 43 sitesUnited States
- Study dates
- Aug 2002to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant had completed the Year 1 of Study M02-433 (NCT00055497)
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
Who cannot join
- Diagnosis of ulcerative colitis
- Pregnancy or breastfeeding
- Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists
- Previous history of active tuberculosis or listeria infection
- Previous history of cancer other than successfully treated skin cancer
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Digestive Disorders Associates
Annapolis, Maryland, 21401
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, 60005
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, 30342
Northwest Gastroenterology
Bellevue, Washington, 98004
Gastroenterology Associates of the East Bay
Berkeley, California, 94705
Deaconess Billings Clinic Research Division
Billings, Montana, 59101
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, 06606
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207
Carolina Research Associates
Charlotte, North Carolina, 28262
Charlottesville Medical Research
Charlottesville, Virginia, 22902
Diseases of the Digestive System
Chattanooga, Tennessee, 37421
University of Chicago
Chicago, Illinois, 60637
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Long Island Clinical Research Associates
Great Neck, New York, 11021
Gastroenterology and Hepatology
Kansas City, Missouri, 64131
NY Center for Clinical Research
Lake Success, New York, 11042
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, 68503
Long Beach Gastroenterology Assoc.
Long Beach, California, 90806
Drug Research Services, Inc.
Metairie, Louisiana, 70001
Glenn Gordon, MD
Mexico, Missouri, 65265
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
Nashville Medical Research Institute
Nashville, Tennessee, 37205
LSU School of Medicine
New Orleans, Louisiana, 70115
New York Presbyterian Hospital
New York, New York, 10021
Daniel Present
New York, New York, 10029
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, 73104
Peter Molloy, MD
Pittsburgh, Pennsylvania, 15224
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, 55905
Rochester Institute for Digestive Diseases
Rochester, New York, 14607
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
Southeastern Digestive & Liver Disease
Savannah, Georgia, 31404
Inland Empire Gastroenterology
Spokane, Washington, 99204
Tacoma Digestive Disease Center
Tacoma, Washington, 98405
Research Solutions
Tulsa, Oklahoma, 74104
Cleveland Clinic Florida
Weston, Florida, 33331
Wake Research Associates
Weston, Florida, 33331
Digestive Health Specialists
Winston-Salem, North Carolina, 27103
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Clinical Pharmacology Study Group
Worchester, Massachusetts, 01610
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
Read the detailed description
Study M02-433 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohn's disease (CD). The study consisted of 2 phases: 1. a 1-year phase (Week 0 to Week 56) (NCT00055497) that consisted of a randomized, double-blind, placebo-controlled portion with a concomitant open label (OL) portion, and 2. a long-term open-label extension (OLE) phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Participants who completed the lead-in study NCT00055523, were eligible to participate in the rollover study, NCT00055497. 176 participants were documented as having completed Year 1 (NCT00055497); however, 177 participants were still receiving study drug and were evaluated at Week 56 of NCT00055497; these participants are included in the OLE data (NCT01070303).
At Week 4 of NCT00055497, participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score <150 points) at Baseline of NCT00055497 and who remained in clinical remission at Week 4 ("Remitters") were randomized to receive 1 of 3 blinded treatments: placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg every week (ew). Participants who did not demonstrate clinical remission at Baseline of NCT00055497 or who were no longer in clinical remission at Week 4 of NCT00055497 ("Non-remitters") were assigned to receive OL adalimumab 40 mg eow. All study drug (placebo and active) was administered by subcutaneous (SC) injection.
At any time during Study NCT00055497, a participant receiving blinded study drug who developed a disease flare could be switched to OL adalimumab 40 mg eow. A participant receiving OL adalimumab 40 mg SC eow who developed a flare or was a non-responders could have had his/her dose increased to 40 mg SC ew.
After 1 year (Week 56 of NCT00055497), patients who were still participating could continue in the OLE phase (NCT01070303). Participants who were receiving blinded study drug were switched to OL adalimumab 40 mg SC eow, and participants who were receiving OL study drug continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or ew).
Data are summarized for Remitters and Non-remitters, with the exception of data for primary reason for noncompletion. Summaries of primary reason for noncompletion were available only for all participants, not for Remitters and Non-remitters. Data are reported for Weeks 104, 152, 212, and 260 of Study M02-433, starting from Week 0 of NCT00055497; these weeks correspond to 1, 2, 3, and 4 years of participation in NCT01070303. Change from Baseline results (clinical response 70, clinical response 100, Inflammatory Bowel Disease Questionnaire, and fistula remission) are calculated from Baseline of the lead-in study (NCT00055523). Results on each assessment at each measurement time point are presented as individual outcome measures because different numbers of participants were evaluated at each time point (as observed analysis).
- Conditions
- Crohn's Disease
- Being tested
- Adalimumab 40 mg eow or ew
- Keywords
- HUMIRA, adalimumab, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab 40 mg eow or ewBiological
Also called Adalimumab, Humira
Adalimumab 40 mg by subcutaneous injection every other week or every week
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab 40 mg every other week or every week | Experimental | Not described Receives: Biological: Adalimumab 40 mg eow or ew |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
Measured: Week 104
Secondary outcomes (24)
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
Measured: Week 152
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
Measured: Week 212
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
Measured: Week 260
Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 104
Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 152
Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 212
Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 260
Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: Week 104
Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in Study to Week 152
Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)
CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 212
Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 260
Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
Measured: From Baseline of lead-in study to Week 104
Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
Measured: From Baseline of lead-in study to Week 152
Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
Measured: From Baseline of lead-in study to Week 212
Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
Measured: From Baseline of lead-in study to Week 260
Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
Measured: From Baseline of lead-in study to Week 104
Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
Measured: From Baseline of lead-in study to Week 152
Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
Measured: From Baseline of lead-in study to Week 212
Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
Measured: From Baseline of lead-in study to Week 260
Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.
Measured: Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248
Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
Measured: From Baseline of lead-in study to Week 104
Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
Measured: From Baseline of lead-in study to Week 152
Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
Measured: From Baseline of lead-in study to Week 212
Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
Measured: From Baseline of lead-in study to Week 260
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startAug 2002
- Primary completionDec 2008
- Study completionDec 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anne Camez, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070303
- Sponsor's protocol ID
- M02-433 Open Label
- Acronym
- CLASSICII
- Status last verified
- Apr 2011
- First submitted
- 16 Feb 2010
- Last updated
- 11 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29380251
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension
- ClinicalTrials.gov ID
- NCT01070303
- Acronym / sponsor ID
- CLASSICII / M02-433 Open Label
- Conditions
- Crohn's Disease
- Keywords
- HUMIRA, adalimumab, Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Posted 7 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
Detailed description
Study M02-433 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohn's disease (CD). The study consisted of 2 phases: 1. a 1-year phase (Week 0 to Week 56) (NCT00055497) that consisted of a randomized, double-blind, placebo-controlled portion with a concomitant open label (OL) portion, and 2. a long-term open-label extension (OLE) phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Participants who completed the lead-in study NCT00055523, were eligible to participate in the rollover study, NCT00055497. 176 participants were documented as having completed Year 1 (NCT00055497); however, 177 participants were still receiving study drug and were evaluated at Week 56 of NCT00055497; these participants are included in the OLE data (NCT01070303).
At Week 4 of NCT00055497, participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score <150 points) at Baseline of NCT00055497 and who remained in clinical remission at Week 4 ("Remitters") were randomized to receive 1 of 3 blinded treatments: placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg every week (ew). Participants who did not demonstrate clinical remission at Baseline of NCT00055497 or who were no longer in clinical remission at Week 4 of NCT00055497 ("Non-remitters") were assigned to receive OL adalimumab 40 mg eow. All study drug (placebo and active) was administered by subcutaneous (SC) injection.
At any time during Study NCT00055497, a participant receiving blinded study drug who developed a disease flare could be switched to OL adalimumab 40 mg eow. A participant receiving OL adalimumab 40 mg SC eow who developed a flare or was a non-responders could have had his/her dose increased to 40 mg SC ew.
After 1 year (Week 56 of NCT00055497), patients who were still participating could continue in the OLE phase (NCT01070303). Participants who were receiving blinded study drug were switched to OL adalimumab 40 mg SC eow, and participants who were receiving OL study drug continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or ew).
Data are summarized for Remitters and Non-remitters, with the exception of data for primary reason for noncompletion. Summaries of primary reason for noncompletion were available only for all participants, not for Remitters and Non-remitters. Data are reported for Weeks 104, 152, 212, and 260 of Study M02-433, starting from Week 0 of NCT00055497; these weeks correspond to 1, 2, 3, and 4 years of participation in NCT01070303. Change from Baseline results (clinical response 70, clinical response 100, Inflammatory Bowel Disease Questionnaire, and fistula remission) are calculated from Baseline of the lead-in study (NCT00055523). Results on each assessment at each measurement time point are presented as individual outcome measures because different numbers of participants were evaluated at each time point (as observed analysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40 mg every other week or every week | Experimental | Biological: Adalimumab 40 mg eow or ew |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant had completed the Year 1 of Study M02-433 (NCT00055497)
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
Key exclusion criteria (5 listed)
- Diagnosis of ulcerative colitis
- Pregnancy or breastfeeding
- Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists
- Previous history of active tuberculosis or listeria infection
- Previous history of cancer other than successfully treated skin cancer
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 |
|---|---|---|
| Adalimumab 40 mg eow or ewAlso: Adalimumab, HumiraAdalimumab 40 mg by subcutaneous injection every other week or every week | Biological | Adalimumab 40 mg every other week or every week |
Primary outcome
Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).
Time frame: Week 104
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
24 secondary outcomes
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).
Time frame: Week 152
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).
Time frame: Week 212
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).
Time frame: Week 260
Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 104
Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 152
Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 212
Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 260
Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)
Time frame: Week 104
Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in Study to Week 152
Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 212
Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 260
Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 104
Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 152
Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 212
Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 260
Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 104
Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 152
Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 212
Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 260
Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
Time frame: Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248
Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 104
Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 152
Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 212
Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)
Time frame: From Baseline of lead-in study to Week 260
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29380251Ryan 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.
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.
Anne Camez, MD study director
Abbott
43 sites 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 40 mg eow or ew in people with Crohn's Disease, run by Abbott at 43 sites 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 3 inclusion and 5 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 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites 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 7 May 2010). 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?
Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). (time frame: Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070303, which also lists 1 linked publication.
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 11 Apr 2011.