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Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus (ADDRESS II)

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ClinicalTrials.gov Identifier: NCT01972568
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : October 26, 2017
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Atacicept 75 milligram (mg)
Drug: Atacicept 150 mg
Drug: Placebo
Enrollment 306
Recruitment Details The study was conducted at 136 sites in 18 countries in Asia, Europe, North America, Central America, and South America.
Pre-assignment Details  
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks. Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks. Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Period Title: Overall Study
Started 102 104 100
Completed 86 92 84
Not Completed 16 12 16
Reason Not Completed
Other events             3             0             0
Lack of Efficacy             0             1             2
Protocol Violation             1             2             2
Withdrawal by Subject             6             3             7
Lost to Follow-up             1             0             0
Adverse Event             5             6             5
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo Total
Hide Arm/Group Description Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks. Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks. Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 102 104 100 306
Hide Baseline Analysis Population Description
Modified intent-to-treat (mITT) analysis set included all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 104 participants 100 participants 306 participants
37  (11.2) 39  (11.6) 40  (13.0) 39  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 100 participants 306 participants
Female
93
  91.2%
97
  93.3%
90
  90.0%
280
  91.5%
Male
9
   8.8%
7
   6.7%
10
  10.0%
26
   8.5%
1.Primary Outcome
Title Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
Hide Description SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Measure Type: Number
Unit of Measure: percentage of subjects
57.8 53.8 44.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atacicept 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1208
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
0.89 to 2.72
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
Hide Description SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Measure Type: Number
Unit of Measure: percentage of subjects
55.9 55.8 41.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atacicept 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0202
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
1.11 to 3.46
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity
Hide Description BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects whose CS dose >=10 mg at Screening.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 56 53 53
Measure Type: Number
Unit of Measure: percentage of subjects
17.9 11.3 18.9
4.Secondary Outcome
Title Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24
Hide Description The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Measure Type: Number
Unit of Measure: percentage of subjects
Very much or much improved 57.8 53.8 46.0
Minimally improved or no change or minimally worse 39.2 44.2 46.0
Much or very much worse 2.0 1.0 6.0
Missing 1.0 1.0 2.0
5.Secondary Outcome
Title Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24
Hide Description Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.
Time Frame Screening and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Mean (Standard Deviation)
Unit of Measure: mg per day
-2.64  (6.106) -1.87  (4.653) -1.89  (5.588)
6.Secondary Outcome
Title Time From Randomization to First SRI Response During Treatment Period
Hide Description SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.
Time Frame Baseline up to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Median (95% Confidence Interval)
Unit of Measure: weeks
12.4
(12.1 to 16.7)
16.1
(12.0 to 16.4)
16.1
(12.1 to 20.1)
7.Secondary Outcome
Title Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24
Hide Description The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 88 100 93
Measure Type: Number
Unit of Measure: percentage of subjects
53.4 49.0 45.2
8.Secondary Outcome
Title Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Hide Description An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE 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. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Time Frame Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized subjects who received at least 1 dose of IMP.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Measure Type: Number
Unit of Measure: percentage of subjects
TEAEs 81.4 80.8 72.0
Serious TEAEs 8.8 5.8 12.0
9.Secondary Outcome
Title Change From Week 0 (Day 1) in SF-36 Components at Week 24
Hide Description The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.
Time Frame Week 0 (Day 1) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here "Number Analyzed" signifies those subjects who were evaluable for this outcome measure at specified categories.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 102 104 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component Summary Number Analyzed 101 participants 100 participants 97 participants
4.7  (7.95) 3.4  (7.57) 3.5  (10.33)
Mental Component Summary Number Analyzed 101 participants 100 participants 97 participants
1.9  (12.01) 1.8  (9.08) 0.7  (11.44)
Physical Functioning Number Analyzed 85 participants 89 participants 82 participants
3.5  (9.30) 3.8  (8.42) 3.3  (8.62)
Role-Physical Number Analyzed 85 participants 89 participants 82 participants
4.3  (10.26) 2.3  (8.64) 3.9  (9.51)
Bodily Pain Number Analyzed 85 participants 89 participants 82 participants
6.0  (10.22) 4.4  (9.30) 5.6  (10.72)
General Health Number Analyzed 84 participants 89 participants 82 participants
2.9  (8.43) 3.0  (7.72) 4.4  (8.00)
Vitality Number Analyzed 84 participants 89 participants 82 participants
3.9  (9.86) 3.7  (9.76) 3.5  (9.57)
Social Functioning Number Analyzed 85 participants 89 participants 82 participants
3.8  (11.45) 2.2  (10.06) 4.3  (11.08)
Role-Emotional Number Analyzed 85 participants 89 participants 82 participants
2.5  (12.71) 1.0  (10.43) 2.3  (10.99)
Mental Health Number Analyzed 84 participants 89 participants 82 participants
2.3  (12.30) 2.8  (8.87) 2.1  (10.60)
10.Post-Hoc Outcome
Title High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24
Hide Description SRI-6 response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 6 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Logistic regression of number of subjects with SRI-6 response was analyzed by using Logistic regression model.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT_HDA analysis set included mITT population with high disease activity (HDA) defined as screening SLE Disease Activity Index (SLEDAI) >=10.
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description:
Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
Overall Number of Participants Analyzed 55 51 52
Measure Type: Number
Unit of Measure: percentage of subjects
43.6 54.9 28.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atacicept 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.31
Confidence Interval (2-Sided) 95%
1.44 to 7.61
Estimation Comments [Not Specified]
Time Frame Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atacicept 75 mg Atacicept 150 mg Placebo
Hide Arm/Group Description Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks. Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks. Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
All-Cause Mortality
Atacicept 75 mg Atacicept 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atacicept 75 mg Atacicept 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/102 (8.82%)   6/104 (5.77%)   12/100 (12.00%) 
Blood and lymphatic system disorders       
Iron deficiency anaemia * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Thrombocytopenia * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Cardiac disorders       
Angina pectoris * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Cardiac failure congestive * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Mitral valve prolapse * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Right ventricular dilatation * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Congenital, familial and genetic disorders       
Atrial septal defect * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Gastrointestinal disorders       
Dyspepsia * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Infections and infestations       
Abscess neck * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Appendicitis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Arthritis bacterial * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Bronchitis * 1  1/102 (0.98%)  0/104 (0.00%)  1/100 (1.00%) 
Cardiac valve vegetation * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Cellulitis * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Endocarditis bacterial * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Gastroenteritis * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Gastroenteritis viral * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Infective aortitis * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Lymph node abscess * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Nasopharyngitis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Ophthalmic herpes zoster * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Parotitis * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Peritonitis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Pharyngitis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Pneumonia * 1  1/102 (0.98%)  0/104 (0.00%)  1/100 (1.00%) 
Pyelonephritis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Sinusitis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Sinusitis bacterial * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Streptococcal bacteraemia * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Streptococcal sepsis * 1  0/102 (0.00%)  1/104 (0.96%)  1/100 (1.00%) 
Urinary tract infection * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Injury, poisoning and procedural complications       
Ligament injury * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Metabolism and nutrition disorders       
Acidosis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Osteonecrosis * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Systemic lupus erythematosus * 1  1/102 (0.98%)  0/104 (0.00%)  2/100 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lipoma * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Nervous system disorders       
Headache * 1  1/102 (0.98%)  0/104 (0.00%)  0/100 (0.00%) 
Sciatica * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Temporal lobe epilepsy * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Renal and urinary disorders       
Acute kidney injury * 1  0/102 (0.00%)  0/104 (0.00%)  2/100 (2.00%) 
Reproductive system and breast disorders       
Metrorrhagia * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Uterine haemorrhage * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Aspiration * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Interstitial lung disease * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Pulmonary hypertension * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Pulmonary oedema * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Respiratory failure * 1  0/102 (0.00%)  0/104 (0.00%)  1/100 (1.00%) 
Skin and subcutaneous tissue disorders       
Angioedema * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Vascular disorders       
Hypertension * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
Peripheral artery occlusion * 1  0/102 (0.00%)  1/104 (0.96%)  0/100 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atacicept 75 mg Atacicept 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   83/102 (81.37%)   84/104 (80.77%)   72/100 (72.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  8/102 (7.84%)  12/104 (11.54%)  5/100 (5.00%) 
Nausea * 1  9/102 (8.82%)  5/104 (4.81%)  1/100 (1.00%) 
General disorders       
Fatigue * 1  6/102 (5.88%)  3/104 (2.88%)  2/100 (2.00%) 
Injection site pain * 1  12/102 (11.76%)  14/104 (13.46%)  7/100 (7.00%) 
Injection site reaction * 1  42/102 (41.18%)  43/104 (41.35%)  19/100 (19.00%) 
Infections and infestations       
Nasopharyngitis * 1  6/102 (5.88%)  7/104 (6.73%)  5/100 (5.00%) 
Upper respiratory tract infection * 1  10/102 (9.80%)  13/104 (12.50%)  3/100 (3.00%) 
Urinary tract infection * 1  12/102 (11.76%)  12/104 (11.54%)  17/100 (17.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  4/102 (3.92%)  3/104 (2.88%)  7/100 (7.00%) 
Nervous system disorders       
Headache * 1  11/102 (10.78%)  15/104 (14.42%)  8/100 (8.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01972568     History of Changes
Other Study ID Numbers: 700461-023
2013-002773-21 ( EudraCT Number )
First Submitted: October 24, 2013
First Posted: October 30, 2013
Results First Submitted: September 29, 2017
Results First Posted: October 26, 2017
Last Update Posted: January 2, 2018