Trial · NCT01440231
Atacicept Demonstrating Dose RESponSe
NCT01440231, Phase 2, Withdrawn, EMD Serono
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atacicept Demonstrating Dose RESponSe. Trials, record NCT01440231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01440231
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atacicept Demonstrating Dose RESponSe
- NCT number
- NCT01440231
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo, Atacicept, Atacicept, Atacicept, Atacicept
- First posted
- 2011-09-26
- Last updated
- 2013-08-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline (trial day 1) in SLEDAI-2K Responder Index-50 (SRI-50) at week 24 of therapy | 24 weeks | The SRI-50 is a modification of the SLEDAI-2K, and allows detection of partial improvements (at least 50%) in SLE signs and symptoms assessed by SLEDAI-2K (Systemic Lupus Erythamtosus Disease Activity Index- 2000). |
| Secondary | Change from baseline to Week 24 in corticosteroid dose | 24 weeks | |
| Secondary | Change from baseline in serum Complement C3 levels at week 24 in subjects with low C3 at baseline | 24 weeks | |
| Secondary | Change from baseline in serum Complement C4 levels at week 24 in subjects with low C4 at baseline | 24 weeks | |
| Secondary | Change from baseline in anti-dsDNA antibodies (in subjects with anti dsDNA ≥30 IU/mL at baseline) and in ANA levels (in subjects with HEp-2 ANA ≥1:80 at baseline) at week 24 | 24 weeks | |
| Secondary | Change from baseline in levels of total Ig and Ig classes (IgG, IgA, and IgM) at week 24 | 24 weekls | |
| Secondary | The nature (preferred terms) and incidence of AEs | 24 weeks | Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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/NCT01440231
GET https://conductscience.org/api/trials/v1/NCT01440231/registered