Trial · NCT00941707
An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis
NCT00941707, Phase 2, Terminated, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis. Trials, record NCT00941707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00941707
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis
- NCT number
- NCT00941707
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 86 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Rheumatoid Arthritis
- Interventions
- JNJ 38518168, Placebo
- First posted
- 2009-07-20
- Last updated
- 2013-04-23
- Other registries' IDs
- eudract:2009-012118-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12 | Baseline and Week 12 | The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant'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 | Percentage of Participants With DAS28 (CRP) Response | Week 12 | The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, proximal 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 | Percentage of Participants With DAS28 (ESR) Response | Week 12 | The DAS28 based on erythrocyte sedimentation rate (ESR) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR and global health (GH). The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). |
| Secondary | Change From Baseline in DAS28 (ESR) Score at Week 12 | Baseline and Week 12 | The DAS28 based on ESR is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR, and GH. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). |
| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR20) Response | Week 12 | The ACR20 response is defined as more than or equal to (\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter (mm), 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. |
| Secondary | Percentage of Participants Achieving ACR50 Response | Week 12 | The ACR50 response is defined as \>=0 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=50 percent improvement in 3 of the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP. |
| Secondary | ACR-N Index Score | Week 12 | The ACR-N Index of improvement is defined as the minimum of the following 3 criteria: percent improvement from Baseline in tender joint counts, percent improvement from Baseline in swollen joint counts and median percent improvement from Baseline for the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP. Negative numbers indicate worsening. |
| Secondary | Change From Baseline in HAQ-DI at Week 12 | Baseline and Week 12 | 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 to 3 (0=no difficulty and 3=inability to perform a task in that area). |
| Secondary | Change From Baseline in Participant's Assessment of Pain at Week 12 | Baseline and Week 12 | Participants will assess their average pain on a VAS. The scale ranges from 0 mm to 100 mm, (0 mm=no pain to 100 mm=worst possible pain). |
| Secondary | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Baseline and Week 12 | The Investigator's global disease assessments will be recorded on a VAS. The scale for the Investigator's assessments ranges from 0 mm to 100 mm (0 mm=no arthritis activity, 100 mm=extremely active arthritis). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT00941707
GET https://conductscience.org/api/trials/v1/NCT00941707/registered