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| ID | Type | Description | Link |
|---|---|---|---|
| 38518168ARA2003 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-006325-18 | EudraCT Number |
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The study was stopped due to lack of efficacy in a study conducted in a similar population,38518168ARA2002-NCT01679951.
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The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of JNJ-38518168 over one year.
This is a randomized (participants assigned to treatment by chance), double-blind (participants and study personnel will not know what treatment is being given), placebo-controlled (a placebo appears identical to a study drug, but contains no active ingredients), parallel-group (treatments will be given to groups of participants at the same time) study. Participants will be randomly assigned in a 3:1 ratio to receive either JNJ-38518168 for 52 weeks or receive matching placebo for 12 weeks, followed by JNJ-38518168 for 40 weeks. The total duration of participation will be approximately 60 weeks for all participants, including a screening visit and follow-up visits. Safety and tolerability of JNJ-38518168 will be evaluated by monitoring adverse events reported by participants throughout the study . In addition, results from clinical laboratory tests, electrocardiograms, vital signs measurements, and physical examinations performed during the study will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-38518168 | Experimental | JNJ-38518168 30 mg once daily for 52 weeks. |
|
| Placebo/JNJ-38518168 | Placebo Comparator | Matching placebo once daily for 12 weeks followed by JNJ-38518168 30 mg once daily for 40 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-38518168 | Drug | JNJ-38518168 30 mg once daily, Week 0 to Week 52. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of rheumatoid arthritis (RA) biomarkers | Biomarkers may include, but are not limited to, inflammatory markers and cytokines; synovium/cartilage/bone markers; and gene expression profiles. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting adverse events as a measure of safety and tolerability | Up to Week 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frederick | Maryland | United States | ||||
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Drug | Matching placebo once daily (Week 0 to Week 12). |
|
| Methotrexate | Drug | All participants will continue receiving methotrexate up to Week 12. After Week 12, the dose of methotrexate may be adjusted as per Investigator's discretion. |
|
| Chisinau |
| Moldova |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |