Trial · NCT00771030
Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
NCT00771030, Phase 1, Phase 2, Completed, Amgen; results first posted 2021-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis. Trials, record NCT00771030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00771030
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
- NCT number
- NCT00771030
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Rheumatoid Arthritis
- Interventions
- Brodalumab, Placebo
- First posted
- 2008-10-10
- Last updated
- 2021-11-26
- Results first posted
- 2021-11-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | From first dose of study drug up to end of study (week 19). | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard. |
| Primary | Number of Participants With Clinically Significant Changes in Safety Laboratory Tests | Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127. | The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported. |
| Primary | Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings | From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6. | |
| Primary | Number of Participants With Anti-brodalumab Antibodies | Days 1 (pre-dose), 29 (pre-dose), 85, and 127 | Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab. |
| Secondary | Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | |
| Secondary | Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | |
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | |
| Secondary | Accumulation Ratio for Brodalumab After Subcutaneous Dosing | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose). |
| Secondary | Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. | |
| Secondary | Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Treatment-emergent Adverse Events | From first dose of study drug up to end of study (week 19). | All randomized participants who received at least 1 dose of study drug (placebo or brodalumab). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Safety Laboratory Tests | Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings | From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Anti-brodalumab Antibodies | Days 1 (pre-dose), 29 (pre-dose), 85, and 127 | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | Participants who received subcutaneously administered brodalumab with available data | days | MEDIAN |
| SECONDARY | Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | Participants who received subcutaneously administered brodalumab with available data | μg/mL | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | Participants who received subcutaneously administered brodalumab with available data | days*μg/mL | MEAN |
| SECONDARY | Accumulation Ratio for Brodalumab After Subcutaneous Dosing | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | Participants who received subcutaneously administered brodalumab with available data | ratio | MEAN |
| SECONDARY | Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. | Participants who received brodalumab by intravenous infusion with available data | hours | MEDIAN |
| SECONDARY | Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. | Participants who received brodalumab by intravenous infusion with available data | μg/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group105
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 Treatment-emergent Adverse Events | Placebo SC (Cohorts 1-3) | Any treatment-emergent adverse event (TEAE) | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Placebo IV (Cohorts 5-6) | Any treatment-emergent adverse event (TEAE) | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Brodalumab 50 mg SC (Cohort 1) | Any treatment-emergent adverse event (TEAE) | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Brodalumab 140 mg SC (Cohort 2) | Any treatment-emergent adverse event (TEAE) | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Brodalumab 210 mg SC (Cohort 3) | Any treatment-emergent adverse event (TEAE) | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Brodalumab 420 mg IV (Cohort 5) | Any treatment-emergent adverse event (TEAE) | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Brodalumab 700 mg IV (Cohort 6) | Any treatment-emergent adverse event (TEAE) | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Placebo SC (Cohorts 1-3) | Serious TEAEs | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Placebo IV (Cohorts 5-6) | Serious TEAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Brodalumab 50 mg SC (Cohort 1) | Serious TEAEs | 0 | Participants |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo SC (Cohorts 1-3) | 6 | |
| Overall Study | STARTED | Placebo IV (Cohorts 5-6) | 4 | |
| Overall Study | STARTED | Brodalumab 50 mg SC (Cohort 1) | 6 | |
| Overall Study | STARTED | Brodalumab 140 mg SC (Cohort 2) | 6 | |
| Overall Study | STARTED | Brodalumab 210 mg SC (Cohort 3) | 6 | |
| Overall Study | STARTED | Brodalumab 420 mg IV (Cohort 5) | 6 | |
| Overall Study | STARTED | Brodalumab 700 mg IV (Cohort 6) | 6 | |
| Overall Study | Received Study Drug | Placebo SC (Cohorts 1-3) | 6 | |
| Overall Study | Received Study Drug | Placebo IV (Cohorts 5-6) | 4 | |
| Overall Study | Received Study Drug | Brodalumab 50 mg SC (Cohort 1) | 6 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events546
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 | Anaemia | Blood and lymphatic system disorders | Placebo SC (Cohorts 1-3) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo IV (Cohorts 5-6) | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 50 mg SC (Cohort 1) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 140 mg SC (Cohort 2) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 210 mg SC (Cohort 3) | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 420 mg IV (Cohort 5) | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Brodalumab 700 mg IV (Cohort 6) | 0 | 6 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo SC (Cohorts 1-3) | 0 | 6 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo IV (Cohorts 5-6) | 0 | 4 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Brodalumab 50 mg SC (Cohort 1) | 0 | 6 |
1 to 10 of 546Source ClinicalTrials.gov
See all 546 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo SC (Cohorts 1-3) | ||
| Total, all-cause mortality | Placebo IV (Cohorts 5-6) | ||
| Total, all-cause mortality | Brodalumab 50 mg SC (Cohort 1) | ||
| Total, all-cause mortality | Brodalumab 140 mg SC (Cohort 2) | ||
| Total, all-cause mortality | Brodalumab 210 mg SC (Cohort 3) | ||
| Total, all-cause mortality | Brodalumab 420 mg IV (Cohort 5) | ||
| Total, all-cause mortality | Brodalumab 700 mg IV (Cohort 6) | ||
| Total, other adverse events | Placebo SC (Cohorts 1-3) | 3 | 6 |
| Total, other adverse events | Placebo IV (Cohorts 5-6) | 4 | 4 |
| Total, other adverse events | Brodalumab 50 mg SC (Cohort 1) | 5 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24286136 | DERIVED |
Source PubMed
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/NCT00771030
GET https://conductscience.org/api/trials/v1/NCT00771030/results?page=2