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| ID | Type | Description | Link |
|---|---|---|---|
| 38518168ARA2002 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-002840-29 | EudraCT Number |
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The decision was made to prematurely discontinue this trial due to lack of efficacy.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| JNJ-38518168 (3 mg/d) | Experimental |
| |
| JNJ-38518168 (10 mg/d) | Experimental |
| |
| JNJ-38518168 (30 mg/d) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Form=tablet, route=oral. Placebo will be administered once daily from week 0 to week 24. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
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| 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. |
|
| JNJ-38518168 (30 mg) | Drug | Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks. |
|
| Methotrexate | 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. |
|
| 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 |
| DAS28 (ESR) remission rates at Week 12 and Week 24 | 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). | Week 12 and Week 24 |
| Hybrid ACR response at Week 12 and Week 24 | The hybrid ACR response is a continuous variable that is limited to an overall score of -100 (maximal worsening) to +100 (maximal improvement). | Week 12 and Week 24 |
| ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24 | According to the ACR/EULAR provisional definition, a patients RA can be defined as being in remission based on either of 2 definitions: when scores on the tender joint count, swollen joint count, CRP (in mg/dL), and patient global assessment (0-10 scale) are all less than or equal to 1 OR when the score on the simplified disease activity index (SDAI) is less than or equal to 3.3 Analyses based on each definition will be performed. | Week 12 and Week 24 |
| Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24 | The SDAI is the numerical sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment of disease activity (PGA VAS in cm), physician global assessment of disease activity (MDGA VAS in cm) and C-reactive protein (CRP in mg/dL). | Baseline, Week 12 and Week 24 |
| Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24 | The CDAI is the numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA, and MDGA. | Baseline, Week 12 and Week 24 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24 | The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). | Week 12 and Week 24 |
| Change from baseline in HAQ-DI score at Week 12 and Week 24 | Baseline, Week 12 and Week 24 |
| Percent change from baseline in ESR levels at Week 12 and Week 24 | Baseline, Week 12 and Week 24 |
| Percent change from baseline in ACR components at Week 12 and Week 24 | Baseline, Week 12 and Week 24 |
| Number of patients with adverse events | Up to Week 28 |
| 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 |
| Adazi | 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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