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CNTO 148

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Johnson & Johnson|Last Updated: Nov 3, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment580

FDA Designations

No designations recorded

Clinical trial landscape

CNTO 148 · 2 trials · 1 indication

Phase 3 2
NCT00727987A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid Arthritis
COMPLETED269 Analytics
NCT00771251A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)Rheumatoid Arthritis
COMPLETED311 Analytics
PHASE3COMPLETED
A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Rheumatoid ArthritisUnlock trial analytics
PHASE3COMPLETED
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

ACR 20% response
Week 14

Secondary Endpoints

ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire)
Week 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CNTO 148 50 mg + methotrexateEXPERIMENTAL -
CNTO 148 100 mg + methotrexateEXPERIMENTAL -
Placebo + methotrexatePLACEBO_COMPARATOR -
CNTO 148 50 mgEXPERIMENTAL -
CNTO 148 100 mgEXPERIMENTAL -
PlaceboEXPERIMENTAL -

Interventions

NameTypeDescription
CNTO 148DRUG50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.
PlaceboDRUGPlacebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.
Methotrexate (MTX)DRUG6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
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Eligibility Criteria

Age Range20 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatol...

Countries:Japan
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Frequently asked questions about CNTO 148

What is CNTO 148 used for?

CNTO 148, also known as golimumab, is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is studied in patients with active rheumatoid arthritis, including those who have not responded adequately to methotrexate therapy.

What does CNTO 148 target?

CNTO 148 targets tumor necrosis factor alpha (TNF-alpha), a key cytokine involved in the inflammatory process of rheumatoid arthritis. By inhibiting TNF-alpha, CNTO 148 aims to reduce inflammation and joint damage associated with the disease.

Who makes CNTO 148?

CNTO 148 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with rheumatoid arthritis.

What phase is CNTO 148 in?

CNTO 148 is in Phase 3 clinical development. Two Phase 3 trials have been completed, both focusing on patients with active rheumatoid arthritis. The drug is still investigational and has not been approved for commercial use.

What clinical trials is CNTO 148 in?

CNTO 148 has been studied in two completed Phase 3 trials: NCT00727987, which enrolled 269 patients with active rheumatoid arthritis despite methotrexate therapy, and NCT00771251, which enrolled 311 patients with active rheumatoid arthritis. Both trials were conducted in Japan.

Is CNTO 148 the same as golimumab?

Yes, CNTO 148 is also known as golimumab. The drug is being developed under the code name CNTO 148, and golimumab is the international nonproprietary name. Both names refer to the same investigational therapy for rheumatoid arthritis.