Trial · NCT00950989
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
NCT00950989, Phase 2, Completed, Amgen; results first posted 2021-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate. Trials, record NCT00950989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00950989
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
- NCT number
- NCT00950989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 252 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Rheumatoid Arthritis
- Interventions
- Brodalumab, Placebo, Methotrexate, folic acid
- First posted
- 2009-08-03
- Last updated
- 2021-12-21
- Results first posted
- 2021-12-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Baseline, week 12 | A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * 50% improvement in 68 tender joint count; * 50% improvement in 66 swollen joint count; and * 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement. |
| Secondary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline, Week 12 | A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * 20% improvement in 68 tender joint count; * 20% improvement in 66 swollen joint count; and * 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement. |
| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Baseline, week 12 | A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: * 70% improvement in 68 tender joint count; * 70% improvement in 66 swollen joint count; and * 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement. |
| Secondary | Disease Activity Score 28 (DAS28) at Week 12 | Week 12 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of tender joints assessed using the 28-jount count and number of swollen joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity (measured on a 0-10 Likert scale). The DAS28 score ranges from 0 to 10, with higher scores indicating more severe disease activity. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | From first dose of study drug until the end of study; median (min, max) duration was 113 days (8, 132). | AEs are defined as any untoward medical occurrence, that does not necessarily have a causal relationship with this treatment. SAEs are defined as an AE that: is fatal; is life threatening (places the subject at immediate risk of death); requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; other significant medical hazard. The severity of events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0: mild=grade 1, moderate=grade 2, severe=grade 3, life-threatening=grade 4, death=grade 5. |
| Secondary | Pharmacokinetics (PK) of Brodalumab: Maximum Observed Concentration (Cmax) | Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose | |
| Secondary | PK of Brodalumab: Time to Maximum Observed Concentration (Tmax) | Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose | |
| Secondary | PK of Brodalumab: Area Under the Curve During the Dosing Interval (AUCtau) | Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Baseline, week 12 | Full Analysis Set: all randomized participants with an assessment. Non-responder imputation. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline, Week 12 | Full Analysis Set: all randomized participants with an assessment. Non-responder imputation. | percentage of partcipants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Baseline, week 12 | Full Analysis Set: all randomized participants with an assessment. Non-responder imputation. | percentage of participants | NUMBER |
| SECONDARY | Disease Activity Score 28 (DAS28) at Week 12 | Week 12 | Full Analysis Set: all randomized participants with an assessment. Last observation carried forward (LOCF). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | From first dose of study drug until the end of study; median (min, max) duration was 113 days (8, 132). | Safety Analysis Set: all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK) of Brodalumab: Maximum Observed Concentration (Cmax) | Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose | Participants who received brodalumab with an evaluable PK measurement. | µg/mL | MEAN |
| SECONDARY | PK of Brodalumab: Time to Maximum Observed Concentration (Tmax) | Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose | Participants who received brodalumab with an evaluable PK measurement. | days | MEDIAN |
| SECONDARY | PK of Brodalumab: Area Under the Curve During the Dosing Interval (AUCtau) | Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose | Participants who received AMG 827 with an evaluable PK measurement. | µg*day/mL | MEAN |
Source ClinicalTrials.gov
Results by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Placebo | 12.7 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Brodalumab 70 mg | 15.9 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Brodalumab 140 mg | 15.9 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Brodalumab 210 mg | 9.5 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Placebo | 42.9 | percentage of partcipants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Brodalumab 70 mg | 39.7 | percentage of partcipants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Brodalumab 140 mg | 36.5 | percentage of partcipants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Brodalumab 210 mg | 46.0 | percentage of partcipants | ||
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Placebo | 3.2 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Brodalumab 70 mg | 3.2 | percentage of participants |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 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 | 63 | |
| Overall Study | STARTED | Brodalumab 70 mg | 63 | |
| Overall Study | STARTED | Brodalumab 140 mg | 63 | |
| Overall Study | STARTED | Brodalumab 210 mg | 63 | |
| Overall Study | COMPLETED | Placebo | 59 | |
| Overall Study | COMPLETED | Brodalumab 70 mg | 60 | |
| Overall Study | COMPLETED | Brodalumab 140 mg | 60 | |
| Overall Study | COMPLETED | Brodalumab 210 mg | 63 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Brodalumab 70 mg | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | Injection site pain | General disorders | Placebo | 4 | 63 | |
| other | Injection site pain | General disorders | Brodalumab 70 mg | 2 | 63 | |
| other | Injection site pain | General disorders | Brodalumab 140 mg | 2 | 63 | |
| other | Injection site pain | General disorders | Brodalumab 210 mg | 2 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 2 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Brodalumab 70 mg | 3 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Brodalumab 140 mg | 4 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Brodalumab 210 mg | 4 | 63 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 63 | |
| other | Upper respiratory tract infection | Infections and infestations | Brodalumab 70 mg | 4 | 63 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Brodalumab 70 mg | ||
| Total, all-cause mortality | Brodalumab 140 mg | ||
| Total, all-cause mortality | Brodalumab 210 mg | ||
| Total, other adverse events | Placebo | 18 | 63 |
| Total, other adverse events | Brodalumab 70 mg | 19 | 63 |
| Total, other adverse events | Brodalumab 140 mg | 25 | 63 |
| Total, other adverse events | Brodalumab 210 mg | 12 | 63 |
| Total, serious adverse events | Placebo | 2 | 63 |
| Total, serious adverse events | Brodalumab 70 mg | 1 | 63 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25877498 | BACKGROUND |
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/NCT00950989
GET https://conductscience.org/api/trials/v1/NCT00950989/results?page=2