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anakinra

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Nov 26, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

anakinra · 3 trials · 2 indications

Phase 3 1Phase 2 2
NCT00117091Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid Arthritis
COMPLETED- Analytics
PHASE3COMPLETED
Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

% of subjects continuing Kineret® therapy at the end of the study (I.e., responders according to pre-defined response assessment criteria.)
The primary outcome of the study was to evaluate the safety of anakinra
28 weeks

Secondary Endpoints

Change in Health Related Quality of Life (HRQOL) scores at the end of study weeks 12, 24, 36 and 48.
feasibility of simpleject device
treatment response (ACR scores, DAS 28) at the end of study weeks 12, 24, 36 and 48.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placeboPLACEBO_COMPARATOR -
anakinraEXPERIMENTAL -

Interventions

NameTypeDescription
Anakinra (Kineret®)DRUG -
anakinraDRUG -
pegsunerceptDRUG -
PlaceboDRUGplacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Subjects diagnosed with RA as determined by American College of Rheumatology (ACR) criteria with a disease duration of at least 24 weeks prior to enrollment - Active RA at screening as defined by EITHER: (1) At least 6 swollen joints (using a 66 joint count) and at least 6 tend...

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Frequently asked questions about anakinra

What is Anakinra used for?

Anakinra is an investigational drug being studied for the treatment of rheumatoid arthritis and juvenile chronic arthritis. It is in Phase 2 clinical development for these indications. Anakinra is being developed by Amgen Inc. (NASDAQ: AMGN) and is a small molecule immunology therapy.

How does Anakinra work?

Anakinra is a small molecule immunology therapy being studied for rheumatoid arthritis and juvenile chronic arthritis. It is being evaluated in placebo-controlled clinical trials to assess its efficacy in reducing disease activity. The drug is administered to patients aged 2 years and older in clinical studies.

Who makes Anakinra?

Anakinra is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical trials for rheumatoid arthritis and juvenile chronic arthritis, with two completed studies involving a total of 86 participants.

What phase is Anakinra in?

Anakinra is in Phase 2 clinical development for rheumatoid arthritis and juvenile chronic arthritis. It has completed two Phase 2 trials, including one with 86 patients with juvenile chronic arthritis. Anakinra is not approved and remains an investigational drug under clinical evaluation.

What clinical trials is Anakinra in?

Anakinra has been studied in two completed Phase 2 trials. NCT00037648 evaluated anakinra in 86 patients with juvenile chronic arthritis, while NCT00037700 assessed anakinra combined with pegsunercept in rheumatoid arthritis. Both trials were randomized, double-blind, and placebo-controlled.

Is Anakinra the same as Kineret?

Anakinra is also known as Kineret, as referenced in the clinical trial NCT00117091, which studied anakinra (Kineret) in combination with disease-modifying anti-rheumatic drugs in patients with active rheumatoid arthritis. This trial was Phase 3 and completed, though it is not part of the Phase 2 development program.