Trial · NCT02683239
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Baseline up to week 52 | The safety analysis set for the evaluation of long-term safety (SAF-LTS) included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Serious TEAE | Baseline up to week 52 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Adverse Event (AE) up to Week 72 | Baseline up to week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Serious AE up to Week 72 | Baseline up to week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adjudicated Arthropathy (AA) | Baseline up to week 52 and week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria | Baseline up to week 52 and week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation | Baseline up to week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Sympathetic Nervous System (SNS) Dysfunction | Baseline up to week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery | Baseline up to weeks 52, 72, and end of study (52 weeks post last dose) | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 | Baseline to week 52 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72 | End of treatment up to week 72 | The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Anti-drug Antibody (ADA) up to Week 72 | Baseline up to week 72 | The ADA analysis set for the long-term safety population included all participants who received any study drug (SAF-LTS) and had at least 1 non-missing ADA result following the first dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score | Baseline to Week 16 | The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category. | Score on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score | Baseline to Week 16 | The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis | Baseline to Week 16 | The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score | Baseline to Week 16 | The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category. Participants with missing data are considered as a non-response. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02683239/outcomes