Trial · NCT00430495
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
NCT00430495, Phase 2, Completed, EMD Serono; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I). Trials, record NCT00430495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00430495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
- NCT number
- NCT00430495
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 256 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Rheumatoid Arthritis
- Interventions
- Atacicept, Atacicept, Atacicept, Placebo matched to atacicept
- First posted
- 2007-02-02
- Last updated
- 2016-02-17
- Results first posted
- 2016-02-17
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 Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 | Week 26 | ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 | Week 26 | ACR50-CRP response is defined as \>=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26 | Week 26 | ACR70-CRP response is defined as \>=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). |
| Secondary | Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26 | Week 26 | DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission. |
| Secondary | Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26 | Week 26 | DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission. |
| Secondary | Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26 | Week 26 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported. |
| Secondary | Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26 | Week 26 | The EULAR response criteria evaluate change in DAS28 scores represented as "good response", "moderate response", or "no response" considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have "good" or "moderate" EULAR response if at the time of assessment, their DAS28 score was \<=5.1 and the improvement from baseline in their DAS28 score was greater than (\>) 0.6; or if at the time of assessment, their DAS28 score was \>5.1 and improvement from baseline in their DAS28 score was \>1.2. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 38 | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. |
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 Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26 | Week 26 | ITT population included all randomized participants who received at least 1 treatment dose. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 38 | Safety population included all randomized participants who received at least 1 treatment dose and had safety data following their first dose. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 | Placebo | 29.0 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 | Atacicept 25 mg | 30.3 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 | Atacicept 75 mg | 27.4 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 | Atacicept 150 mg | 39.1 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 | Placebo | 6.5 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 | Atacicept 25 mg | 13.6 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 | Atacicept 75 mg | 11.3 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26 | Atacicept 150 mg | 10.9 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26 | Placebo | 0.0 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26 | Atacicept 25 mg | 6.1 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | STARTED | Atacicept 25 mg | 66 | |
| Overall Study | STARTED | Atacicept 75 mg | 62 | |
| Overall Study | STARTED | Atacicept 150 mg | 64 | |
| Overall Study | Treated | Placebo | 62 | |
| Overall Study | Treated | Atacicept 25 mg | 66 | |
| Overall Study | Treated | Atacicept 75 mg | 62 | |
| Overall Study | Treated | Atacicept 150 mg | 64 | |
| Overall Study | COMPLETED | Placebo | 50 | |
| Overall Study | COMPLETED | Atacicept 25 mg | 59 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events172
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 | Upper respiratory tract infection | Infections and infestations | Placebo | 4 | 62 | |
| other | Upper respiratory tract infection | Infections and infestations | Atacicept 25 mg | 3 | 66 | |
| other | Upper respiratory tract infection | Infections and infestations | Atacicept 75 mg | 0 | 62 | |
| other | Upper respiratory tract infection | Infections and infestations | Atacicept 150 mg | 8 | 64 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 3 | 62 | |
| other | Urinary tract infection | Infections and infestations | Atacicept 25 mg | 4 | 66 | |
| other | Urinary tract infection | Infections and infestations | Atacicept 75 mg | 3 | 62 | |
| other | Urinary tract infection | Infections and infestations | Atacicept 150 mg | 5 | 64 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 62 | |
| other | Nasopharyngitis | Infections and infestations | Atacicept 25 mg | 3 | 66 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 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 | Atacicept 25 mg | ||
| Total, all-cause mortality | Atacicept 75 mg | ||
| Total, all-cause mortality | Atacicept 150 mg | ||
| Total, other adverse events | Placebo | 15 | 62 |
| Total, other adverse events | Atacicept 25 mg | 25 | 66 |
| Total, other adverse events | Atacicept 75 mg | 16 | 62 |
| Total, other adverse events | Atacicept 150 mg | 26 | 64 |
| Total, serious adverse events | Placebo | 3 | 62 |
| Total, serious adverse events | Atacicept 25 mg | 9 | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21452293 | 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/NCT00430495
GET https://conductscience.org/api/trials/v1/NCT00430495/results?page=2