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Anakinra

Phase 4

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

Anakinra development status

Highest phase Phase 4 run by Swedish Orphan Biovitrum (NCT06666335)
Phase scored for AMGNPhase 3
Registered trials 9 across 7 sponsors since May 2002

Anakinra target and mechanism

Molecular targetIL1R1
Target classAntagonist
ModalitySmall molecule

Also known as Anakinra (Kineret®)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment86

FDA Designations

No designations recorded

Anakinra clinical trials

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 used for the treatment of Juvenile Chronic Arthritis and Rheumatoid Arthritis. It is an immunology therapy developed by Amgen Inc. (ticker: AMGN) and is also known by the brand name Kineret. The drug is currently in Phase 2 clinical development for these indications.

What does Anakinra target?

Anakinra targets the interleukin-1 receptor type 1 (IL1R1). It acts as an antagonist at this receptor, blocking interleukin-1 signaling. This mechanism is intended to reduce inflammation associated with Juvenile Chronic Arthritis and Rheumatoid Arthritis.

Who makes Anakinra?

Anakinra is developed by Amgen Inc., which trades under the ticker symbol AMGN. The company is responsible for the clinical development of the drug, also known as Kineret, for immunology indications including Juvenile Chronic Arthritis and Rheumatoid Arthritis.

What phase is Anakinra in?

Anakinra is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for the indications described. The development program includes completed Phase 2 and Phase 3 trials in Rheumatoid Arthritis and Juvenile Chronic Arthritis.

What clinical trials is Anakinra in?

Anakinra has been studied in completed clinical trials including NCT00117091, a Phase 3 trial in Rheumatoid Arthritis; NCT00037700, a Phase 2 trial in Rheumatoid Arthritis; and NCT00037648, a Phase 2 trial in Juvenile Chronic Arthritis with 86 participants. No active trials are currently listed.

Is Anakinra the same as Kineret?

Yes, Anakinra is also known by the brand name Kineret. Kineret is the registered trademark name for the same drug. Both names refer to the interleukin-1 receptor antagonist developed by Amgen Inc. for immunology indications.