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Enbrel

Phase 3

Ankylosing Spondylitis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Dec 13, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment234

FDA Designations

No designations recorded

Clinical trial landscape

Enbrel · 3 trials · 2 indications

Phase 3 2Phase 1 1
NCT00434044Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing SpondylitisAnkylosing Spondylitis
COMPLETED150 Analytics
NCT00421915Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisAnkylosing Spondylitis
COMPLETED84 Analytics
PHASE3COMPLETED
Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Ankylosing SpondylitisUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
Ankylosing SpondylitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.
To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
To assess the pharmacokinetics of etanercept in healthy Chinese male subjects.

Secondary Endpoints

ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.
To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Enbrel (etanercept)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Must be of Chinese ancestry and living in China. 2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis. 3. Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness...

Countries:China
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Frequently asked questions about Enbrel

What is Enbrel used for?

Enbrel is used for the treatment of ankylosing spondylitis and psoriasis. It is also studied in healthy subjects for pharmacokinetic evaluation. The drug is in Phase 3 clinical development for these indications, with completed trials in ankylosing spondylitis and psoriasis.

Who makes Enbrel?

Enbrel is developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with ankylosing spondylitis and psoriasis.

What phase is Enbrel in?

Enbrel is in Phase 3 clinical development. Clinical trials have been completed for ankylosing spondylitis and psoriasis, with a total of 421 participants enrolled across studies. The drug is investigational and not yet approved for these indications.

What clinical trials is Enbrel in?

Enbrel has completed Phase 3 trials including NCT00421915 and NCT00434044 for ankylosing spondylitis, and NCT00482170 for psoriasis. A Phase 1 trial, NCT00502879, studied the drug in healthy Chinese male subjects. All trials are completed.

Is Enbrel the same as etanercept?

Yes, Enbrel is the same as etanercept. Clinical trial titles refer to etanercept as the active substance. The drug is being studied for ankylosing spondylitis and psoriasis, with completed Phase 3 trials.