Trial · NCT00664521
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
NCT00664521, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2016-12-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III). Trials, record NCT00664521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00664521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
- NCT number
- NCT00664521
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Rheumatoid Arthritis
- Interventions
- Rituximab, Atacicept, Placebo matched to atacicept
- First posted
- 2008-04-23
- Last updated
- 2016-12-30
- Results first posted
- 2016-12-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 64 | 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 defined as 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. |
| Primary | Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) | Week 64 | |
| Primary | Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Baseline, Week 32 | Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as (\[Week 32 value minus baseline value\] multiplied by 100) divided by baseline value. |
| Primary | Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32 | Baseline, Week 32 | Percent change from baseline was calculated as (\[Week 32 value minus baseline value\] multiplied by 100) divided by baseline value. |
| Primary | Percent Change From Baseline in Anti-pneumococcus Titer at Week 32 | Baseline, Week 32 | Percent change from baseline was calculated as (\[Week 32 value minus baseline value\] multiplied by 100) divided by baseline value. |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32 | Week 32 | ACR20-CRP response: 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: 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). ACR50-CRP and ACR70-CRP response are defined as \>=50% and \>=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) respectively together with \>=50% and \>=70% improvement in at least 3 of the following respectively: 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) CRP. |
| Secondary | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32 | Baseline, Week 32 | 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 score 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 | Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells | Baseline, Week 3, 7, 12, 16, 26 and 32 | Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels. |
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 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 64 | Safety population included all participants who received at least one dose of atacicept or placebo. | Participants | NUMBER |
| PRIMARY | Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) | Week 64 | Safety population included all participants who received at least one dose of atacicept or placebo. Here. N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Baseline, Week 32 | Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32 | Baseline, Week 32 | Safety population included all participants who received at least one dose of atacicept or placebo. Here. N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| PRIMARY | Percent Change From Baseline in Anti-pneumococcus Titer at Week 32 | Baseline, Week 32 | Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32 | Week 32 | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32 | Baseline, Week 32 | ITT population included all randomized participants. Here 'n' signifies those participants who were evaluable for the specified category. | Units on a scale | MEAN |
| SECONDARY | Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells | Baseline, Week 3, 7, 12, 16, 26 and 32 | Safety population included all participants who received at least one dose of atacicept or placebo. Here 'n' signifies those participants who were evaluable for the specified category. | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group120
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 Adverse Events (AEs) and Serious Adverse Events (SAEs) | Rituximab Plus Atacicept | AEs | 17 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Rituximab Plus Placebo | AEs | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Rituximab Plus Atacicept | SAEs | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Rituximab Plus Placebo | SAEs | 2 | Participants | |
| Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) | Rituximab Plus Atacicept | 0 | percentage of participants | ||
| Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) | Rituximab Plus Placebo | 0 | percentage of participants | ||
| Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Rituximab Plus Atacicept | Systolic Blood Pressure (n = 12, 9) | 3.74 | Standard Deviation 11.76 | Percent change |
| Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Rituximab Plus Placebo | Systolic Blood Pressure (n = 12, 9) | -6.29 | Standard Deviation 13.80 | Percent change |
| Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Rituximab Plus Atacicept | Diastolic Blood Pressure (n = 12, 9) | 1.09 | Standard Deviation 11.19 | Percent change |
| Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Rituximab Plus Placebo | Diastolic Blood Pressure (n = 12, 9) | 4.89 | Standard Deviation 10.09 | Percent change |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab Plus Atacicept | 18 | |
| Overall Study | STARTED | Rituximab Plus Placebo | 9 | |
| Overall Study | COMPLETED | Rituximab Plus Atacicept | 12 | |
| Overall Study | COMPLETED | Rituximab Plus Placebo | 8 | |
| Overall Study | NOT COMPLETED | Rituximab Plus Atacicept | 6 | |
| Overall Study | NOT COMPLETED | Rituximab Plus Placebo | 1 |
Source ClinicalTrials.gov
Adverse events228
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 | Rituximab Plus Atacicept | 3 | 18 | |
| other | Upper respiratory tract infection | Infections and infestations | Rituximab Plus Placebo | 3 | 9 | |
| other | Influenza | Infections and infestations | Rituximab Plus Atacicept | 2 | 18 | |
| other | Influenza | Infections and infestations | Rituximab Plus Placebo | 1 | 9 | |
| other | Rhinitis | Infections and infestations | Rituximab Plus Atacicept | 2 | 18 | |
| other | Rhinitis | Infections and infestations | Rituximab Plus Placebo | 0 | 9 | |
| other | Urinary tract infection | Infections and infestations | Rituximab Plus Atacicept | 1 | 18 | |
| other | Urinary tract infection | Infections and infestations | Rituximab Plus Placebo | 1 | 9 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Rituximab Plus Atacicept | 1 | 18 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Rituximab Plus Placebo | 1 | 9 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab Plus Atacicept | ||
| Total, all-cause mortality | Rituximab Plus Placebo | ||
| Total, other adverse events | Rituximab Plus Atacicept | 17 | 18 |
| Total, other adverse events | Rituximab Plus Placebo | 9 | 9 |
| Total, serious adverse events | Rituximab Plus Atacicept | 6 | 18 |
| Total, serious adverse events | Rituximab Plus Placebo | 2 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26137975 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rituximab Plus Atacicept vs Rituximab Plus Placebo: serious adverse events |
Source Trial comparisons
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/NCT00664521
GET https://conductscience.org/api/trials/v1/NCT00664521/results?page=2