Trial · NCT00595413

Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

NCT00595413, Phase 2, Completed, EMD Serono; results first posted 2016-02-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II). Trials, record NCT00595413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00595413

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
NCT number: NCT00595413
Status: Completed
Phases: Phase 2
Enrollment: 311 participants, actual
Lead sponsor: EMD Serono
Conditions: Rheumatoid Arthritis
Interventions: Placebo matched to atacicept, Atacicept: with loading dose, Atacicept, Adalimumab
First posted: 2008-01-16
Last updated: 2016-02-17
Results first posted: 2016-02-17

Source ClinicalTrials.gov

Registered outcomes5

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 from Baseline 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 from Baseline 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 from Baseline 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 from Baseline 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 from Baseline 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 from Baseline 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 With Good or Moderate European League Against Rheumatism (EULAR) Responses 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 less than or equal to (\<=) 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 Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38	An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (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

Outcomes5

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 study 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 study 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 study treatment dose.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26	Week 26	ITT population included all randomized participants who received at least 1 study treatment dose.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38	ITT population included all randomized participants who received at least 1 study treatment dose.	participants	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26	Placebo	46.1	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 With Loading Dose	44.9	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 Without Loading Dose	57.7	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26	Adalimumab	70.9	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26	Placebo	14.5	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26	Atacicept 150 mg With Loading Dose	29.5	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26	Atacicept 150 mg Without Loading Dose	33.3	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26	Adalimumab	38.0	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26	Placebo	5.3	percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26	Atacicept 150 mg With Loading Dose	12.8	percentage of participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	76
Overall Study	STARTED	Atacicept 150 mg With Loading Dose	78
Overall Study	STARTED	Atacicept 150 mg Without Loading Dose	78
Overall Study	STARTED	Adalimumab	79
Overall Study	COMPLETED	Placebo	69
Overall Study	COMPLETED	Atacicept 150 mg With Loading Dose	73
Overall Study	COMPLETED	Atacicept 150 mg Without Loading Dose	70
Overall Study	COMPLETED	Adalimumab	75
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Atacicept 150 mg With Loading Dose	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events124

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
other	Bronchitis	Infections and infestations	Placebo	4	76
other	Bronchitis	Infections and infestations	Atacicept 150 mg With Loading Dose	5	78
other	Bronchitis	Infections and infestations	Atacicept 150 mg Without Loading Dose	6	78
other	Bronchitis	Infections and infestations	Adalimumab	3	79
other	Nasopharyngitis	Infections and infestations	Placebo	6	76
other	Nasopharyngitis	Infections and infestations	Atacicept 150 mg With Loading Dose	2	78
other	Nasopharyngitis	Infections and infestations	Atacicept 150 mg Without Loading Dose	4	78
other	Nasopharyngitis	Infections and infestations	Adalimumab	5	79
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	76
other	Upper respiratory tract infection	Infections and infestations	Atacicept 150 mg With Loading Dose	4	78

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse 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 150 mg With Loading Dose
Total, all-cause mortality	Atacicept 150 mg Without Loading Dose
Total, all-cause mortality	Adalimumab
Total, other adverse events	Placebo	23	76
Total, other adverse events	Atacicept 150 mg With Loading Dose	27	78
Total, other adverse events	Atacicept 150 mg Without Loading Dose	24	78
Total, other adverse events	Adalimumab	22	79
Total, serious adverse events	Placebo	2	76
Total, serious adverse events	Atacicept 150 mg With Loading Dose	4	78

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21452294	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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