Crohn's DiseasePhase 3CLASSICIINCT00055497
Remission in Subjects With Crohn's Disease, 1 Year Phase
A Phase 3 study testing DB adalimumab 40 mg eow, DB adalimumab 40 mg ew and OL adalimumab 40 mg 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 maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks. 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?
- DB adalimumab 40 mg eow, DB adalimumab 40 mg ew and OL adalimumab 40 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 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
- Patient must have successfully completed the induction study NCT00055523
- 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 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
The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.
Read the detailed description
Study NCT00055497 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. the first year phase lasting until Week 56 and consisting of a randomized, double-blind (DB), placebo-controlled portion (NCT00055497) and of a concomitant open label (OL) portion, and 2. a long-term extension phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Potential participants were screened at the time of enrollment in the lead-in, induction therapy study (NCT00055523). Participants who completed the lead-in study, NCT00055523, were eligible to participate in the rollover study, NCT00055497.
In Study NCT00055497, all participants received 40 mg of adalimumab subcutaneously (SC) at Baseline (Week 0) and Week 2 of Study NCT00055497. Baseline of Study NCT00055497 is synonymous with NCT00055523 Week 4. At Week 4 of Study NCT00055497, participants were randomized based on their clinical remission status at Baseline and Week 4 of Study NCT00055497. Participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score < 150 points) at Baseline of Study NCT00055497 and who remained in clinical remission at Week 4 of Study NCT00055497 (those participants constituted the randomized analysis set) were randomized to receive 1 of 3 blinded treatments: adalimumab 40 mg every other week (eow), adalimumab 40 mg every week (ew), or placebo. Participants who did not demonstrate clinical remission at Baseline of Study NCT00055497, or who were no longer in clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40 mg eow; those participants constituted the OL analysis set. At any time during Study NCT00055497, participants receiving OL adalimumab 40 mg SC eow who developed a flare or were non-responders during OL treatment could have had his/her dose increased to 40 mg SC weekly. Participants who were documented as having completed Week 56 are counted in the study completion total.
After 1 year (Week 56), participants who met eligibility criteria for the long-term extension phase (NCT01070303) were switched to OL adalimumab 40 mg subcutaneous (SC) eow, and participants previously in the OL treatment group of Study NCT00055497 continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or every week).
- Conditions
- Crohn's Disease
- Being tested
- Double-blind (DB) adalimumab placebo, DB adalimumab 40 mg eow, DB adalimumab 40 mg ew, OL adalimumab 40 mg
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-blind (DB) adalimumab placeboBiological
Also called Humira®
Double-blind nonactive matching subcutaneous injection
DB adalimumab 40 mg eowBiological
Also called Humira®
Double-blind adalimumab 40 mg every other week by subcutaneous injection
DB adalimumab 40 mg ewBiological
Also called Humira®
Double-blind adalimumab 40 mg every week by subcutaneous injection
OL adalimumab 40 mgBiological
Also called Humira®
Open-label adalimumab every other week or every week by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Double-blind (DB) adalimumab placebo | Placebo comparator | Double-blind nonactive matching subcutaneous injection Receives: Biological: Double-blind (DB) adalimumab placebo |
| Double-blind adalimumab 40 mg every other week (eow) | Experimental | Double-blind adalimumab 40 mg eow by subcutaneous injection Receives: Biological: DB adalimumab 40 mg eow |
| Double-blind adalimumab 40 mg every week (ew) | Experimental | Double-blind adalimumab 40 mg every week by subcutaneous injection Receives: Biological: DB adalimumab 40 mg ew |
| Open-label adalimumab 40 mg | Experimental | Open-label adalimumab 40 mg eow or ew by subcutaneous injection Receives: Biological: OL adalimumab 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: Week 56
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: Week 56
Secondary outcomes (9)
Number of Participants Achieving Clinical Remission at Week 24 - NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: Week 56
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 24 and to Week 56
Number of Participants Achieving Clinical Remission at Week 24 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: Week 56
Number of Participants Achieving CR-100 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving CR-70 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Measured: From Baseline of lead-in study to Week 24 and Week 56
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF
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 to Week 24 and Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2003 (estimated)
- Study startAug 2002
- Primary completionJan 2005
- 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 (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 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
- NCT00055497
- Sponsor's protocol ID
- M02-433
- Acronym
- CLASSICII
- Status last verified
- Apr 2011
- First submitted
- 3 Mar 2003
- 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 29380251Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.
PubMed 22344964
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
- ClinicalTrials.gov ID
- NCT00055497
- Acronym / sponsor ID
- CLASSICII / M02-433
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Mar 2003 (estimated)
- Results
- Posted 18 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 maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.
Detailed description
Study NCT00055497 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. the first year phase lasting until Week 56 and consisting of a randomized, double-blind (DB), placebo-controlled portion (NCT00055497) and of a concomitant open label (OL) portion, and 2. a long-term extension phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Potential participants were screened at the time of enrollment in the lead-in, induction therapy study (NCT00055523). Participants who completed the lead-in study, NCT00055523, were eligible to participate in the rollover study, NCT00055497.
In Study NCT00055497, all participants received 40 mg of adalimumab subcutaneously (SC) at Baseline (Week 0) and Week 2 of Study NCT00055497. Baseline of Study NCT00055497 is synonymous with NCT00055523 Week 4. At Week 4 of Study NCT00055497, participants were randomized based on their clinical remission status at Baseline and Week 4 of Study NCT00055497. Participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score < 150 points) at Baseline of Study NCT00055497 and who remained in clinical remission at Week 4 of Study NCT00055497 (those participants constituted the randomized analysis set) were randomized to receive 1 of 3 blinded treatments: adalimumab 40 mg every other week (eow), adalimumab 40 mg every week (ew), or placebo. Participants who did not demonstrate clinical remission at Baseline of Study NCT00055497, or who were no longer in clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40 mg eow; those participants constituted the OL analysis set. At any time during Study NCT00055497, participants receiving OL adalimumab 40 mg SC eow who developed a flare or were non-responders during OL treatment could have had his/her dose increased to 40 mg SC weekly. Participants who were documented as having completed Week 56 are counted in the study completion total.
After 1 year (Week 56), participants who met eligibility criteria for the long-term extension phase (NCT01070303) were switched to OL adalimumab 40 mg subcutaneous (SC) eow, and participants previously in the OL treatment group of Study NCT00055497 continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or every week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Double-blind (DB) adalimumab placebo | Placebo comparator | Biological: Double-blind (DB) adalimumab placeboDouble-blind nonactive matching subcutaneous injection |
| Double-blind adalimumab 40 mg every other week (eow) | Experimental | Biological: DB adalimumab 40 mg eowDouble-blind adalimumab 40 mg eow by subcutaneous injection |
| Double-blind adalimumab 40 mg every week (ew) | Experimental | Biological: DB adalimumab 40 mg ewDouble-blind adalimumab 40 mg every week by subcutaneous injection |
| Open-label adalimumab 40 mg | Experimental | Biological: OL adalimumab 40 mgOpen-label adalimumab 40 mg eow or ew by subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must have successfully completed the induction study NCT00055523
- 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 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 |
|---|---|---|
| Double-blind (DB) adalimumab placeboAlso: Humira®Double-blind nonactive matching subcutaneous injection | Biological | Double-blind (DB) adalimumab placebo |
| DB adalimumab 40 mg eowAlso: Humira®Double-blind adalimumab 40 mg every other week by subcutaneous injection | Biological | Double-blind adalimumab 40 mg every other week (eow) |
| DB adalimumab 40 mg ewAlso: Humira®Double-blind adalimumab 40 mg every week by subcutaneous injection | Biological | Double-blind adalimumab 40 mg every week (ew) |
| OL adalimumab 40 mgAlso: Humira®Open-label adalimumab every other week or every week by subcutaneous injection | Biological | Open-label adalimumab 40 mg |
Primary outcome
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)
Time frame: Week 56
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)
Time frame: Week 56
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
9 secondary outcomes
Number of Participants Achieving Clinical Remission at Week 24 - NRI
Time frame: Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - NRI
Time frame: Week 56
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
Time frame: From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
Time frame: From Baseline of lead-in study to Week 24 and to Week 56
Number of Participants Achieving Clinical Remission at Week 24 - LOCF
Time frame: Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF
Time frame: Week 56
Number of Participants Achieving CR-100 - LOCF
Time frame: From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving CR-70 - LOCF
Time frame: From Baseline of lead-in study to Week 24 and Week 56
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF
Time frame: Change from Baseline of lead-in study to Week 24 and Week 56
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.
- Derived from this study: PubMed 22344964Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.
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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 DB adalimumab 40 mg eow, DB adalimumab 40 mg ew and OL adalimumab 40 mg 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. Some participants in this study may receive a placebo. 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 18 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 Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) (time frame: Week 56). The study lists 2 primary outcomes in all. 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 NCT00055497, which also lists 2 linked publications.
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.