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Adalimumab eow or ew

Phase 3

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

Adalimumab eow or ew target and mechanism

Molecular targetTNF
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment177

FDA Designations

No designations recorded

Adalimumab eow or ew clinical trials

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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Frequently asked questions about Adalimumab eow or ew

What is Adalimumab eow or ew used for?

Adalimumab eow or ew is used for the treatment of Crohn's Disease, a chronic inflammatory condition of the gastrointestinal tract. It is a monoclonal antibody therapy being studied in a Phase 3 clinical trial. The dosing abbreviation eow or ew refers to every other week or every week administration schedules.

What does Adalimumab eow or ew target?

Adalimumab eow or ew targets TNF, also known as tumor necrosis factor. It is an inhibitor of TNF, a pro-inflammatory cytokine involved in Crohn's Disease. By inhibiting TNF, the drug aims to reduce inflammation in the gastrointestinal tract.

Who is developing Adalimumab eow or ew?

Adalimumab eow or ew is being developed by Abbott Laboratories, which trades under the ticker symbol ABT. Abbott Laboratories is a global healthcare company involved in the research and development of pharmaceutical products.

What phase is Adalimumab eow or ew in?

Adalimumab eow or ew is in Phase 3 clinical development for Crohn's Disease. It is an investigational therapy and has not been approved by the FDA for this indication. The Phase 3 trial has been completed.

What clinical trials is Adalimumab eow or ew in?

Adalimumab eow or ew has been studied in one Phase 3 clinical trial, NCT01070303, titled Remission in Subjects With Crohn's Disease, Open Label Extension. This trial enrolled 177 participants, was conducted in the United States, and has been completed. It was an open-label, uncontrolled study.