Study Stopped
The decision was made to prematurely discontinue this trial due to lack of efficacy.
A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate
A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Dose Range Finding Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy
3 other identifiers
interventional
272
16 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Oct 2012
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2012
CompletedFirst Posted
Study publicly available on registry
September 6, 2012
CompletedStudy Start
First participant enrolled
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2014
CompletedMarch 18, 2019
March 1, 2019
1.5 years
September 3, 2012
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Week 12
Secondary Outcomes (16)
Change from baseline in DAS28 (CRP) at Week 24
Baseline and Week 24
Change from baseline in DAS28 (erythrocyte sedimentation rate [ESR]) at Week 12 and Week 24
Baseline, Week 12 and Week 24
DAS28 (CRP) response rates at Week 12 and Week 24
Week 12 and Week 24
DAS28 (ESR) response rates at Week 12 and Week 24
Week 12 and Week 24
DAS28 (CRP) remission rates at Week 12 and Week 24
Week 12 and Week 24
- +11 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORJNJ-38518168 (3 mg/d)
EXPERIMENTALJNJ-38518168 (10 mg/d)
EXPERIMENTALJNJ-38518168 (30 mg/d)
EXPERIMENTALInterventions
Form=tablet, route=oral. Placebo will be administered once daily from week 0 to week 24.
Type=exact number, unit=mg, number=3, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.
Type=exact number, unit=mg, number=10, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.
Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Unknown Facility
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
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San Miguel de Tucumán, Argentina
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Osorno X Region, Chile
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Santiago, Chile
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Santiago - Macul, Chile
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Viña del Mar, Chile
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Barranquilla, Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Cali, Colombia
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Medellín, Colombia
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Hlučín, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Slaný, Czechia
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Zlín, Czechia
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Gyulai, Hungary
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Veszprém, Hungary
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Chiba, Japan
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Fukuoka, Japan
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Hokkaido, Japan
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Kanagawa, Japan
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Katō, Japan
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Kawagoe, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Matsuyama, Japan
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Osaka, Japan
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Sapporo, Japan
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Takasaki, Japan
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Tokyo, Japan
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Ādaži, Latvia
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Riga, Latvia
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Valmiera, Latvia
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Del Gustavo A Madero, Mexico
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Delegación Cuauhtémoc, Mexico
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Guadalajara, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalaja, Mexico
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León, Mexico
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Mexico City, Mexico
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México, Mexico
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San Luis Potosí City, Mexico
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Bialystok, Poland
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Katowice, Poland
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Nadarzyn, Poland
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Poznan, Poland
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Środa Wielkopolska, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bacau, Romania
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Brăila, Romania
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Bucharest, Romania
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Sibiu, Romania
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Kazan', Russia
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Moscow, Russia
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Novosibirsk, Russia
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Petrozavodsk, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Tver', Russia
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Yaroslavl, Russia
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Daegu, South Korea
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Pucheon, South Korea
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Suwon, South Korea
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Donetsk, Ukraine
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Kyiv, Ukraine
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Vinnytsia, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research and Development, LLC Clinical Trial
Janssen Research and Development LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2012
First Posted
September 6, 2012
Study Start
October 31, 2012
Primary Completion
April 17, 2014
Study Completion
July 3, 2014
Last Updated
March 18, 2019
Record last verified: 2019-03