Trial · NCT01679951
A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate
NCT01679951, Phase 2, Terminated, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate. Trials, record NCT01679951. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01679951
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate
- NCT number
- NCT01679951
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 272 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Rheumatoid Arthritis
- Interventions
- Placebo, JNJ-38518168 (3 mg), JNJ-38518168 (10 mg), JNJ-38518168 (30 mg), Methotrexate
- First posted
- 2012-09-06
- Last updated
- 2019-03-18
- Other registries' IDs
- eudract:2011-002840-29
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Activity Score 28 (DAS28) (C-reactive protein [CRP]) at Week 12 | Baseline and 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. |
| Secondary | Change from baseline in DAS28 (CRP) at Week 24 | Baseline and Week 24 | |
| Secondary | Change from baseline in DAS28 (erythrocyte sedimentation rate [ESR]) at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | |
| Secondary | DAS28 (CRP) response rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | DAS28 (ESR) response rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | DAS28 (CRP) remission rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | DAS28 (ESR) remission rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | American College of Rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24 | 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). |
| Secondary | Hybrid ACR response at Week 12 and Week 24 | 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). |
| Secondary | ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24 | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01679951
GET https://conductscience.org/api/trials/v1/NCT01679951/registered