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Adalimumab eow or ew

Phase 3

Crohn's Disease | Monoclonal antibody | Gastrointestinal |Abbott Laboratories|Last Updated: Apr 11, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment177

FDA Designations

No designations recorded

Clinical trial landscape

Adalimumab eow or ew · 1 trial · 1 indication

Phase 3 1
NCT01070303Remission in Subjects With Crohn's Disease, Open Label ExtensionCrohn's Disease
COMPLETED177 Analytics
PHASE3COMPLETED
Remission in Subjects With Crohn's Disease, Open Label Extension
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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).
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.

Secondary Endpoints

Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).
Week 152
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).
Week 212
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).
Week 260
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Adalimumab 40 mg every other week or every weekEXPERIMENTAL -

Interventions

NameTypeDescription
Adalimumab 40 mg eow or ewBIOLOGICALAdalimumab 40 mg by subcutaneous injection every other week or every week
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * Participant had completed the Year 1 of Study M02-433 (NCT00055497) * Diagnosis of Crohn's disease * Willing and able to give informed consent Exclusion Criteria: * Diagnosis of ulcerative colitis * Pregnancy or breastfeeding * Previous use of infliximab or other anti-TNF (t...

Countries:United States
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