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MTX

Phase 3

Arthritis, Rheumatoid | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Mar 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Clinical trial landscape

MTX · 1 trial · 1 indication

Phase 3 1
NCT00202852A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)Arthritis, Rheumatoid
COMPLETED143 Analytics
PHASE3COMPLETED
A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)
Arthritis, RheumatoidUnlock trial analytics

Study Endpoints

Primary Endpoints

Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit.
30-week follow-up visit.

Secondary Endpoints

Safety evaluations will include measurements of vital signs during and immediately after the infusions of study agents.
During and immediately after the infusions of study agents.
Assessment of adverse events at each of the evaluation visits.
At each evaluation visit.
Routine, laboratory tests (hematology, blood chemistry, and urinalysis) will be performed at Screening, at 2 and 6 weeks, and thereafter every 8 weeks through Week 30 for patients.
At Screening, Week 2, Week 6, and then every 8 weeks thereafter through Week 30.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboOTHERPlacebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
MTXDRUGPlacebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose \>=12.5 mg/week given orally or parenterally, maximum 20 mg/week
InfliximabBIOLOGICALInfliximab 3 mg/kg given as an infusion at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed at least 6 months prior to screening. * Active disease at the time of screening and pre-infusion as defined by: * \>=6 ...

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Frequently asked questions about MTX

What is MTX used for in rheumatoid arthritis?

MTX is a small molecule being studied for the treatment of rheumatoid arthritis. It is currently in Phase 3 clinical development as an investigational therapy for this condition. The drug is being evaluated in patients with rheumatoid arthritis who have not responded adequately to other treatments.

Who makes MTX?

MTX is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of MTX in patients with rheumatoid arthritis.

What phase is MTX in?

MTX is currently in Phase 3 clinical development for the treatment of rheumatoid arthritis. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the data are being analyzed to determine the drug's safety and efficacy profile.

What clinical trials is MTX in?

MTX has been studied in one completed Phase 3 clinical trial, identified as NCT00202852. This trial was a placebo-controlled, double-blinded, randomized study that enrolled 143 patients with rheumatoid arthritis who were also taking methotrexate. The trial was conducted in South Korea and included adult patients aged 18 years and older.

Is MTX the same as Remicade?

MTX is not the same as Remicade. The clinical trial NCT00202852 evaluated the combination of Remicade and methotrexate in patients with rheumatoid arthritis. MTX refers to methotrexate, which is a standard treatment for rheumatoid arthritis, while Remicade is a separate biologic drug. The trial studied the effects of adding Remicade to methotrexate therapy.