Trial · NCT02683239
Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
NCT02683239, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2023-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip. Trials, record NCT02683239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02683239
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
- NCT number
- NCT02683239
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,331 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Osteoarthritis of the Knee or Hip
- Interventions
- Fasinumab, Placebo
- First posted
- 2016-02-17
- Last updated
- 2023-10-13
- Other registries' IDs
- eudract:2015-003783-36
- Results first posted
- 2023-10-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Baseline up to week 52 | |
| Primary | Number of Participants With Any Serious TEAE | Baseline up to week 52 | |
| Primary | Number of Participants With Any Adverse Event (AE) up to Week 72 | Baseline up to week 72 | |
| Primary | Number of Participants With Any Serious AE up to Week 72 | Baseline up to week 72 | |
| Primary | Number of Participants With Adjudicated Arthropathy (AA) | Baseline up to week 52 and week 72 | Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria. |
| Primary | Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria | Baseline up to week 52 and week 72 | DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. |
| Primary | Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation | Baseline up to week 72 | Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI). |
| Primary | Number of Participants With Sympathetic Nervous System (SNS) Dysfunction | Baseline up to week 72 | Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist. |
| 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) | All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug. |
| Primary | Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 | Baseline to week 52 | Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group181
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab-matching Placebo Q4W/Q8W | 1055 | Participants | ||
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab 1 mg SC Q8W | 840 | Participants | ||
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab 1 mg SC Q4W | 885 | Participants | ||
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab 3 mg SC Q4W | 185 | Participants | ||
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab 6 mg SC Q8W | 1487 | Participants | ||
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab 6 mg SC Q4W | 93 | Participants | ||
| Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Fasinumab 9 mg SC Q4W | 92 | Participants | ||
| Number of Participants With Any Serious TEAE | Fasinumab-matching Placebo Q4W/Q8W | 82 | Participants | ||
| Number of Participants With Any Serious TEAE | Fasinumab 1 mg SC Q8W | 57 | Participants | ||
| Number of Participants With Any Serious TEAE | Fasinumab 1 mg SC Q4W | 70 | Participants |
1 to 10 of 181Source ClinicalTrials.gov
See all 181 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fasinumab-matching Placebo Q4W/Q8W | 1,260 | |
| Overall Study | STARTED | Fasinumab 1 mg SC Q8W | 971 | |
| Overall Study | STARTED | Fasinumab 1 mg SC Q4W | 975 | |
| Overall Study | STARTED | Fasinumab 3 mg SC Q4W | 214 | |
| Overall Study | STARTED | Fasinumab 6 mg SC Q8W | 1,680 | |
| Overall Study | STARTED | Fasinumab 6 mg SC Q4W | 116 | |
| Overall Study | STARTED | Fasinumab 9 mg SC Q4W | 115 | |
| Overall Study | COMPLETED | Fasinumab-matching Placebo Q4W/Q8W | 800 | |
| Overall Study | COMPLETED | Fasinumab 1 mg SC Q8W | 738 | |
| Overall Study | COMPLETED | Fasinumab 1 mg SC Q4W | 756 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events3,192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab-matching Placebo Q4W/Q8W | 413 | 1,257 | 771 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab 1mg SC Q8W | 347 | 966 | 636 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab 1mg SC Q4W | 350 | 974 | 633 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab 3mg SC Q4W | 69 | 214 | 109 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab 6mg SC Q8W | 710 | 1,677 | 1,358 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab 6mg SC Q4W | 53 | 116 | 115 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasinumab 9mg SC Q4W | 45 | 115 | 82 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fasinumab-matching Placebo Q4W/Q8W | 204 | 1,257 | 363 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fasinumab 1mg SC Q8W | 207 | 966 | 336 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fasinumab 1mg SC Q4W | 185 | 974 | 301 |
1 to 10 of 3,192Source ClinicalTrials.gov
See all 3,192 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fasinumab-matching Placebo Q4W/Q8W | 9 | 1,257 |
| Total, all-cause mortality | Fasinumab 1mg SC Q8W | 5 | 966 |
| Total, all-cause mortality | Fasinumab 1mg SC Q4W | 8 | 974 |
| Total, all-cause mortality | Fasinumab 3mg SC Q4W | 0 | 214 |
| Total, all-cause mortality | Fasinumab 6mg SC Q8W | 12 | 1,677 |
| Total, all-cause mortality | Fasinumab 6mg SC Q4W | 1 | 116 |
| Total, all-cause mortality | Fasinumab 9mg SC Q4W | 0 | 115 |
| Total, other adverse events | Fasinumab-matching Placebo Q4W/Q8W | 988 | 1,257 |
| Total, other adverse events | Fasinumab 1mg SC Q8W | 793 | 966 |
| Total, other adverse events | Fasinumab 1mg SC Q4W | 817 | 974 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02683239
GET https://conductscience.org/api/trials/v1/NCT02683239/results?page=2