Trial · NCT02070978
Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
NCT02070978, Phase 2, Terminated, EMD Serono; results first posted 2019-03-21
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ConductScience Library. Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II). Trials, record NCT02070978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02070978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
- NCT number
- NCT02070978
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 253 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Atacicept 75 mg, Atacicept 150 mg, Atacicept 150 mg
- First posted
- 2014-02-25
- Last updated
- 2019-03-21
- Other registries' IDs
- eudract:2013-002758-62
- Results first posted
- 2019-03-21
- Limitations and caveats
- The study was terminated early due to shortage of drug supply and there were many fewer number of participants remaining in each dosage group after Week 72 preluding meaningful inferences.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period | Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. 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 or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. Treatment- Emergent adverse events (TEAEs) during the treatment period exclude those ongoing at the time of study entry into 024 LTE Day 1 and exclude the safety follow-up period. |
| Primary | Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) | Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at the 024 LTE study entry, occurring during the 024 LTE study and the Safety follow-up Period. |
| Secondary | Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96 | SLICC/ACR score or damage index evaluates cumulative damage in Systemic Lupus Erythematosus (SLE). These changes may or may not be related to SLE. Most items are scored only if they have been present for at least 6 months. Scores range from 0 to 47 points, with higher scores indicating greater cumulative damage. Baseline was defined as Day 1 of Core study. |
| Secondary | Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score | Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | BILAG Disease Activity Index evaluates systemic lupus erythematosus (SLE) activity in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Severe disease activity; BILAG B: moderate disease activity; BILAG C: mild disease; BILAG D: system previously affected but now inactive; BILAG E: system never involved. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. |
| Secondary | Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Baseline was defined as core study screening visit. |
| Secondary | Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | SRI-50 index was derived from SLEDAI-2K and could capture 50% or better improvement in each descriptor between any 2 visits in systemic lupus erythematosus (SLE) participants when there was incomplete resolution. The new assigned scores for the descriptors of SRI-50 were derived by dividing the score of each SLEDAI-2K descriptor by 2. SLEDAI-2K was an activity index that measured disease activity and records feature of active lupus as present or not present. SLEDAI-2K used a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present was assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranged from 0 points (no symptoms) to 105 points (presence of all defined symptoms). |
| Secondary | Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score | Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96 | The PGA was used to quantify disease activity and was measured using an anchored visual analog scale (VAS). The participant's current disease activity assessed by investigator in the score range of 0 to 3. Where 0=none; 1=mild; 2=moderate; 3=severe. The assessment made relative not to the participant's most severe state, but the most severe state of systemic lupus erythematosus (SLE) per the investigator's assessment. Baseline was defined as core study screening visit. |
| Secondary | Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index) | Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline Physician's Global Assessment of Disease Activity (PGA). SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). |
| Secondary | Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index) | Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | The BICLA response was defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and less than or equal to (\<=1) new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by less than (\<) 0 percentage (%) (defined as less then (\<)0.3 point increase for the statistical analyses) and no non-permitted medication/treatment. Baseline was defined as core study screening visit. |
| Secondary | Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 at Least One Serious Adverse Event (SAE) During the Treatment Period | Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks | The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) | Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks | The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96 | Modified intent-to-treat (mITT) analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score | Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here, Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | Data was not collected for this endpoint as the results from ADDRESS II core study (700461-023; NCT01972568) for SRI-50 were not significant. Therefore, data collection for the SRI-50 for current study (700461-024; NCT02070978) was halted and no analysis was conducted for endpoint. | ||
| SECONDARY | Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score | Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index) | Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was used. For this outcome measure, baseline was measured as reference timepoint for response in the screening visit from core study. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index) | Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT BILAG analysis set included mITT population with at least one BILAG A and/or B at screening visit. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Percent change | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group420
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 at Least One Serious Adverse Event (SAE) During the Treatment Period | Placebo/Atacicept 150 mg | 13 | Participants | ||
| Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period | Atacicept 75 mg | 10 | Participants | ||
| Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period | Atacicept 150 mg | 9 | Participants | ||
| Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) | Placebo/Atacicept 150 mg | 9 | Participants | ||
| Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) | Atacicept 75 mg | 4 | Participants | ||
| Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) | Atacicept 150 mg | 5 | Participants | ||
| Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Placebo/Atacicept 150 mg | Baseline; Day 1 (Core Study) | 1 | Standard Deviation 1.0 | Units on a scale |
| Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Atacicept 75 mg | Baseline; Day 1 (Core Study) | 1 | Standard Deviation 1.2 | Units on a scale |
| Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Atacicept 150 mg | Baseline; Day 1 (Core Study) | 0 | Standard Deviation 0.8 | Units on a scale |
| Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Placebo/Atacicept 150 mg | Change at LTE Day 1 | 0 | Standard Deviation 0.0 | Units on a scale |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Atacicept 150 mg | 83 | |
| Overall Study | STARTED | Atacicept 75 mg | 82 | |
| Overall Study | STARTED | Atacicept 150 mg | 88 | |
| Overall Study | COMPLETED | Placebo/Atacicept 150 mg | 36 | |
| Overall Study | COMPLETED | Atacicept 75 mg | 29 | |
| Overall Study | COMPLETED | Atacicept 150 mg | 35 | |
| Overall Study | NOT COMPLETED | Placebo/Atacicept 150 mg | 47 | |
| Overall Study | NOT COMPLETED | Atacicept 75 mg | 53 | |
| Overall Study | NOT COMPLETED | Atacicept 150 mg | 53 |
Source ClinicalTrials.gov
Adverse events219
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 | Urinary tract infection | Infections and infestations | Placebo/Atacicept 150 mg | 18 | 83 | |
| other | Urinary tract infection | Infections and infestations | Atacicept 75 mg | 14 | 82 | |
| other | Urinary tract infection | Infections and infestations | Atacicept 150 mg | 17 | 88 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo/Atacicept 150 mg | 7 | 83 | |
| other | Upper respiratory tract infection | Infections and infestations | Atacicept 75 mg | 11 | 82 | |
| other | Upper respiratory tract infection | Infections and infestations | Atacicept 150 mg | 15 | 88 | |
| other | Nasopharyngitis | Infections and infestations | Placebo/Atacicept 150 mg | 8 | 83 | |
| other | Nasopharyngitis | Infections and infestations | Atacicept 75 mg | 8 | 82 | |
| other | Nasopharyngitis | Infections and infestations | Atacicept 150 mg | 5 | 88 | |
| other | Bronchitis | Infections and infestations | Placebo/Atacicept 150 mg | 7 | 83 |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/Atacicept 150 mg | 0 | 83 |
| Total, all-cause mortality | Atacicept 75 mg | 0 | 82 |
| Total, all-cause mortality | Atacicept 150 mg | 2 | 88 |
| Total, other adverse events | Placebo/Atacicept 150 mg | 65 | 83 |
| Total, other adverse events | Atacicept 75 mg | 65 | 82 |
| Total, other adverse events | Atacicept 150 mg | 75 | 88 |
| Total, serious adverse events | Placebo/Atacicept 150 mg | 19 | 83 |
| Total, serious adverse events | Atacicept 75 mg | 13 | 82 |
| Total, serious adverse events | Atacicept 150 mg | 11 | 88 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33547784 | 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.
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