A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

Phase 2TerminatedNCT01679951

Janssen Research & Development, LLC272 enrolled

Overview

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), multicenter, placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), dose range finding study of JNJ-38518168 in patients with active RA despite concomitant MTX therapy. The study will consist a screening period, a 24-week placebo-controlled period and a 4-week follow-up period between the last dose and the last visit. The duration of participation in the study for an individual patient will be up to 34 weeks (including screening). The patients will be assigned to 1 of 4 treatment groups in a 1:1:1:1 ratio to placebo and JNJ-38518168 (3 mg or 10 mg or 30 mg). Safety assessments and evaluations to determine the efficacy of JNJ-38518168 to reduce the signs and symptoms of RA will be performed at study visits. Safety will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

272

Conditions

Rheumatoid Arthritis

Interventions

PlaceboDRUG

Form=tablet, route=oral. Placebo will be administered once daily from week 0 to week 24.

JNJ-38518168 (3 mg)DRUG

Type=exact number, unit=mg, number=3, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

JNJ-38518168 (10 mg)DRUG

Type=exact number, unit=mg, number=10, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening * Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening * Must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline and Serum C reactive protein greater than or equal to 0.80 mg/dL at the time of screening * Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening Exclusion Criteria: * Has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy * Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled * Has ever received any approved or investigational biologic agent for a rheumatoid indication * Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent

Locations (85)

Outcomes

Primary Outcomes

Disease Activity Score 28 (DAS28) (C-reactive protein [CRP]) at Week 12

The DAS28 using CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and Patient's Global Assessment of Disease Activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.

Time frame: Baseline and Week 12

Secondary Outcomes

Change from baseline in DAS28 (CRP) at Week 24

Time frame: Baseline and Week 24

Change from baseline in DAS28 (erythrocyte sedimentation rate [ESR]) at Week 12 and Week 24

Time frame: Baseline, Week 12 and Week 24

DAS28 (CRP) response rates at Week 12 and Week 24

Time frame: Week 12 and Week 24

DAS28 (ESR) response rates at Week 12 and Week 24

Time frame: Week 12 and Week 24

DAS28 (CRP) remission rates at Week 12 and Week 24

Time frame: Week 12 and Week 24

DAS28 (ESR) remission rates at Week 12 and Week 24

Time frame: Week 12 and Week 24

American College of Rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24

An ACR 20/50/70 response is defined as a greater than or equal to 20/50/70 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).

Data from ClinicalTrials.gov

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Huntsville, Alabama, United States

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Gilbert, Arizona, United States

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Covina, California, United States

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Palm Harbor, Florida, United States

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Granger, Indiana, United States

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Frederick, Maryland, United States

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Freehold, New Jersey, United States

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Charlotte, North Carolina, United States

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Charleston, South Carolina, United States

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Buenos Aires, Argentina

...and 75 more locations