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Human anti-TNF monoclonal antibody/adalimumab

Phase 3

Psoriatic Arthritis | Monoclonal antibody | Immunology |Abbott Laboratories|Last Updated: Aug 29, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

Human anti-TNF monoclonal antibody/adalimumab · 1 trial · 1 indication

Phase 3 1
NCT00195689Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic ArthritisPsoriatic Arthritis
COMPLETED400 Analytics
PHASE3COMPLETED
Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
Psoriatic ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
FACTIT Fatigue Scale
Disease progression measurements

Secondary Endpoints

Patient reported outcomes
Clinical response indicators
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Human anti-TNF monoclonal antibody/adalimumabBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject completed study M02-518 or M02-570 Exclusion Criteria: * Subject prematurely discontinued study M02-518 or M02-570 * Female subject who is pregnant or breast-feeding or considering becoming pregnant * Subject considered by the investigator, for any reason, to be...

Countries:United States
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Frequently asked questions about Human anti-TNF monoclonal antibody/adalimumab

What is Human anti-TNF monoclonal antibody/adalimumab used for?

Human anti-TNF monoclonal antibody/adalimumab is used for the treatment of psoriatic arthritis. It is a monoclonal antibody being developed for patients with moderate to severely active psoriatic arthritis. The drug is currently in Phase 3 clinical development and is being studied in the United States.

What does Human anti-TNF monoclonal antibody/adalimumab target?

Human anti-TNF monoclonal antibody/adalimumab targets tumor necrosis factor (TNF). As an anti-TNF monoclonal antibody, it is designed to neutralize TNF, a cytokine involved in inflammation. This mechanism is relevant to the treatment of psoriatic arthritis, an inflammatory condition.

Who makes Human anti-TNF monoclonal antibody/adalimumab?

Human anti-TNF monoclonal antibody/adalimumab is being developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The drug is currently in Phase 3 clinical development for psoriatic arthritis.

What phase is Human anti-TNF monoclonal antibody/adalimumab in?

Human anti-TNF monoclonal antibody/adalimumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of psoriatic arthritis.

What clinical trials is Human anti-TNF monoclonal antibody/adalimumab in?

Human anti-TNF monoclonal antibody/adalimumab has one completed Phase 3 clinical trial, identified as NCT00195689. This trial, titled 'Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis,' enrolled 400 participants in the United States. The trial was not randomized, double-blind, or controlled.

Is Human anti-TNF monoclonal antibody/adalimumab the same as adalimumab?

Yes, Human anti-TNF monoclonal antibody/adalimumab is the same as adalimumab. The drug is commonly referred to as adalimumab, and it is being developed by Abbott Laboratories for psoriatic arthritis. It is currently in Phase 3 clinical development.