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

NCT ID: NCT01679951

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-03

Brief Summary

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.

Detailed Description

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Methotrexate

Intervention Type: DRUG

Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.

JNJ-38518168 (3 mg/d)

Group Type: EXPERIMENTAL

JNJ-38518168 (3 mg)

Intervention Type: DRUG

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

Methotrexate

Intervention Type: DRUG

Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.

JNJ-38518168 (10 mg/d)

Group Type: EXPERIMENTAL

JNJ-38518168 (10 mg)

Intervention Type: DRUG

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

Methotrexate

Intervention Type: DRUG

Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.

JNJ-38518168 (30 mg/d)

Group Type: EXPERIMENTAL

JNJ-38518168 (30 mg)

Intervention Type: DRUG

Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

Methotrexate

Intervention Type: DRUG

Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.

Interventions

Placebo

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

Intervention Type: DRUG

JNJ-38518168 (3 mg)

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

Intervention Type: DRUG

JNJ-38518168 (10 mg)

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

Intervention Type: DRUG

JNJ-38518168 (30 mg)

Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

Intervention Type: DRUG

Methotrexate

Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research and Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research and Development LLC

Locations

Huntsville, Alabama, United States

Gilbert, Arizona, United States

Covina, California, United States

Palm Harbor, Florida, United States

Granger, Indiana, United States

Frederick, Maryland, United States

Freehold, New Jersey, United States

Charlotte, North Carolina, United States

Charleston, South Carolina, United States

Buenos Aires, , Argentina

San Miguel de Tucumán, , Argentina

Osorno X Region, , Chile

Santiago, , Chile

Santiago - Macul, , Chile

Viña del Mar, , Chile

Barranquilla, , Colombia

Bogotá, , Colombia

Bucaramanga, , Colombia

Cali, , Colombia

Medellín, , Colombia

Hlučín, , Czechia

Ostrava, , Czechia

Prague, , Czechia

Slaný, , Czechia

Zlín, , Czechia

Balatonfüred, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Gyulai, , Hungary

Veszprém, , Hungary

Chiba, , Japan

Fukuoka, , Japan

Hokkaido, , Japan

Kanagawa, , Japan

Katō, , Japan

Kawagoe, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Matsuyama, , Japan

Osaka, , Japan

Sapporo, , Japan

Takasaki, , Japan

Tokyo, , Japan

Ādaži, , Latvia

Riga, , Latvia

Valmiera, , Latvia

Del Gustavo A Madero, , Mexico

Delegación Cuauhtémoc, , Mexico

Guadalajara, , Mexico

Guadalajara, Jalisco, , Mexico

Guadalaja, , Mexico

León, , Mexico

Mexico City, , Mexico

México, , Mexico

San Luis Potosí City, , Mexico

Bialystok, , Poland

Katowice, , Poland

Nadarzyn, , Poland

Poznan, , Poland

Środa Wielkopolska, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Bacau, , Romania

Brăila, , Romania

Bucharest, , Romania

Sibiu, , Romania

Kazan', , Russia

Moscow, , Russia

Novosibirsk, , Russia

Petrozavodsk, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Tver', , Russia

Yaroslavl, , Russia

Daegu, , South Korea

Pucheon, , South Korea

Suwon, , South Korea

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Donetsk, , Ukraine

Kyiv, , Ukraine

Vinnytsia, , Ukraine

Countries

United States; Argentina; Chile; Colombia; Czechia; Hungary; Japan; Latvia; Mexico; Poland; Romania; Russia; South Korea; Taiwan; Thailand; Ukraine

Other Identifiers

38518168ARA2002

Identifier Type: OTHER

Identifier Source: secondary_id

2011-002840-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100734

Identifier Type: -

Identifier Source: org_study_id