Trial · NCT01059448
Safety and Efficacy of AMG 827 in Subjects With RA
NCT01059448, Phase 2, Terminated, Amgen; results first posted 2022-02-28
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ConductScience Library. Safety and Efficacy of AMG 827 in Subjects With RA. Trials, record NCT01059448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059448
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of AMG 827 in Subjects With RA
- NCT number
- NCT01059448
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 211 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Rheumatoid Arthritis
- Interventions
- AMG 827
- First posted
- 2010-02-01
- Last updated
- 2022-02-28
- Results first posted
- 2022-02-28
- Limitations and caveats
The study was terminated on 18 May 2011 because AMG 827 was not shown to be efficacious in the parent study (Study 20090061) when compared to placebo at any dose as measured by ACR 20, 50, or 70 responses. In addition, there was no observed difference compared to placebo in responses as measured by the individual components of the ACR response criteria.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Treatment-emergent Adverse Event (TEAE) | Day 1 to Week 52 of study 20090402 | A TEAE was defined as an event that occurred after the first dose date and before the end of study date in study 20090402; or an event that was already present prior to the initiation of the investigational product (i.e. present at study 20090402) baseline but worsened in either frequency or severity after the first dose date and before the end of study date in study 20090402. TEAEs also included serious treatment-emergent adverse events and clinically significant changes from baseline in hematology, chemistry and urinalysis profiles and clinically significant changes in vital sign measurements. |
| Primary | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | An ACR 20 response was defined as at least a 20% improvement from baseline in both tender/painful and swollen joint counts, and a 20% improvement or more in at least 3 of the following 5 criteria: physician global assessment of disease activity (PGA), subject global assessment of disease activity (SGA), participant global assessment of joint pain, participant self-assessment of disability (Health Assessment Questionnaire, HAQ-DI), and acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever had a bigger improvement. Participants were excluded from analysis if an ACR 20 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061. |
| Primary | Number of Participants Who Achieved an ACR 50 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | An ACR 50 response was defined as at least a 50% improvement from baseline in both tender/painful and swollen joint counts, and a 50% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 50 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061. |
| Primary | Number of Participants Who Achieved an ACR 70 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | An ACR 70 response was defined as at least a 70% improvement from baseline in both tender/painful and swollen joint counts, and a 70% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 70 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061. |
| Primary | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A negative change from baseline indicated a reduction in disease activity. Baseline refers to the baseline in parent study 20090061. |
| Primary | Number of Participants With a DAS28 Score < 2.6 | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A score of \<2.6 indicated disease activity remission. 1 participant in the Arm "Placebo Q2WK / 210 mg AMG 827 Q2WK" was missing baseline data for DAS28. |
| Primary | DAS28 Score at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. 1 participant in the Arm "Placebo Q2WK / 210 mg AMG 827 Q2WK" was missing baseline data for DAS28. |
| Primary | CRP Levels at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | All blood samples were taken before the dose of IP was administered. Blood samples were processed and sent to the central laboratory. The central laboratory were responsible for completing assessments. |
| Primary | ESR at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | All blood samples were taken before the dose of IP was administered. ESR was performed locally at each site and the ESR data was submitted to the central laboratory. |
Source ClinicalTrials.gov
Outcomes9
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 a Treatment-emergent Adverse Event (TEAE) | Day 1 to Week 52 of study 20090402 | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Achieved an ACR 50 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Achieved an ACR 70 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least 1 dose of AMG 827. | Score on a Scale | MEAN |
| PRIMARY | Number of Participants With a DAS28 Score < 2.6 | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | DAS28 Score at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Score on a Scale | MEAN |
| PRIMARY | CRP Levels at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | Milligrams per Liter (mg/L) | MEAN |
| PRIMARY | ESR at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | FAS - All analyzable participants who were treated with at least one dose of AMG 827. | millimeters per hour (mm/hr) | MEAN |
Source ClinicalTrials.gov
Results by group300
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 a Treatment-emergent Adverse Event (TEAE) | Placebo Q2WK / 210 mg AMG 827 Q2WK | 28 | Participants | ||
| Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 32 | Participants | ||
| Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 31 | Participants | ||
| Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 32 | Participants | ||
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | Placebo Q2WK / 210 mg AMG 827 Q2WK | 20090402 Week 2 | 21 | Participants | |
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 20090402 Week 2 | 24 | Participants | |
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 20090402 Week 2 | 26 | Participants | |
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 20090402 Week 2 | 24 | Participants | |
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | Placebo Q2WK / 210 mg AMG 827 Q2WK | 20090402 Week 4 | 27 | Participants | |
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 20090402 Week 4 | 26 | Participants |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Q2WK / 210 mg AMG 827 Q2WK | 49 | |
| Overall Study | STARTED | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 55 | |
| Overall Study | STARTED | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 53 | |
| Overall Study | STARTED | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 54 | |
| Overall Study | COMPLETED | Placebo Q2WK / 210 mg AMG 827 Q2WK | 0 | |
| Overall Study | COMPLETED | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 0 | |
| Overall Study | COMPLETED | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 0 | |
| Overall Study | COMPLETED | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 0 | |
| Overall Study | NOT COMPLETED | Placebo Q2WK / 210 mg AMG 827 Q2WK | 49 | |
| Overall Study | NOT COMPLETED | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 55 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events92
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 | Vertigo | Ear and labyrinth disorders | Placebo / AMG 827 210 mg Q2WK | 0 | 49 | |
| other | Vertigo | Ear and labyrinth disorders | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 1 | 55 | |
| other | Vertigo | Ear and labyrinth disorders | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 1 | 53 | |
| other | Vertigo | Ear and labyrinth disorders | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 3 | 54 | |
| other | Conjunctivitis | Eye disorders | Placebo / AMG 827 210 mg Q2WK | 0 | 49 | |
| other | Conjunctivitis | Eye disorders | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 3 | 55 | |
| other | Conjunctivitis | Eye disorders | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 0 | 53 | |
| other | Conjunctivitis | Eye disorders | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 1 | 54 | |
| other | Gastritis | Gastrointestinal disorders | Placebo / AMG 827 210 mg Q2WK | 0 | 49 | |
| other | Gastritis | Gastrointestinal disorders | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 4 | 55 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo / AMG 827 210 mg Q2WK | ||
| Total, all-cause mortality | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ||
| Total, all-cause mortality | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ||
| Total, all-cause mortality | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ||
| Total, other adverse events | Placebo / AMG 827 210 mg Q2WK | 15 | 49 |
| Total, other adverse events | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 18 | 55 |
| Total, other adverse events | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 19 | 53 |
| Total, other adverse events | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 22 | 54 |
| Total, serious adverse events | Placebo / AMG 827 210 mg Q2WK | 2 | 49 |
| Total, serious adverse events | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 5 | 55 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01059448
GET https://conductscience.org/api/trials/v1/NCT01059448/results?page=2