Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

Nuon Therapeutics

Status and phase: Completed; Phase 2

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Tranilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882024

A3003RA

Details and patient eligibility

About

The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.

Full description

The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receiving methotrexate
• Have at least 8 painful/tender and 6 swollen joints
• May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

Exclusion criteria

• Use of any anti-arthritic treatments except those allowed in inclusion criteria
• Pregnant or nursing females
• Abnormal laboratory values
• History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence
• Clinically significant systemic infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 3 patient groups, including a placebo group

1 Tranilast

Experimental group

Description:

Tranilast, 300 mg/day

Treatment:

Drug: Tranilast

Drug: Tranilast

2 Tranilast

Experimental group

Description:

Tranilast, 150 mg/day

Treatment:

Drug: Tranilast

Drug: Tranilast

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo