Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I) (AUGUST I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00430495
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Atacicept
Drug: Placebo matched to atacicept
Enrollment 256
Recruitment Details  
Pre-assignment Details A total of 456 subjects were screened, of whom 256 were enrolled and randomized of which 254 received the trial medication and included in Intention to Treat (ITT) population.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Period Title: Overall Study
Started 64 66 62 64
Treated 62 66 62 64
Completed 50 59 49 60
Not Completed 14 7 13 4
Reason Not Completed
Adverse Event             2             3             2             0
Death             0             0             1             0
Lost to Follow-up             0             1             4             0
Protocol Violation             1             0             1             0
Disease Progression             1             1             0             0
Other             8             2             5             4
Randomized but not Treated             2             0             0             0
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Total
Hide Arm/Group Description Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks. Total of all reporting groups
Overall Number of Baseline Participants 62 66 62 64 254
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who received at least one treatment dose.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 66 participants 62 participants 64 participants 254 participants
53.1  (12.5) 53.4  (13.1) 55.3  (12.0) 53.5  (10.1) 53.8  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 66 participants 62 participants 64 participants 254 participants
Female
51
  82.3%
54
  81.8%
53
  85.5%
53
  82.8%
211
  83.1%
Male
11
  17.7%
12
  18.2%
9
  14.5%
11
  17.2%
43
  16.9%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26
Hide Description ACR20-CRP response is defined as 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 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).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: percentage of participants
29.0 30.3 27.4 39.1
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26
Hide Description ACR50-CRP response is defined as >=50% 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 >=50% improvement 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).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: percentage of participants
6.5 13.6 11.3 10.9
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26
Hide Description ACR70-CRP response is defined as >=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) together with >=70% improvement 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).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: percentage of participants
0.0 6.1 4.8 0.0
4.Secondary Outcome
Title Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26
Hide Description 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-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: percentage of participants
9.7 10.6 9.7 12.5
5.Secondary Outcome
Title Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26
Hide Description 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 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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: percentage of participants
1.6 6.1 4.8 4.7
6.Secondary Outcome
Title Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26
Hide Description The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 38 41 34 48
Measure Type: Number
Unit of Measure: percentage of participants
47.4 48.8 55.9 37.5
7.Secondary Outcome
Title Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26
Hide Description 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 <=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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 treatment dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: percentage of participants
41.9 31.8 35.5 53.1
8.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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 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.
Time Frame Baseline up to Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 treatment dose and had safety data following their first dose.
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description:
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Overall Number of Participants Analyzed 62 66 62 64
Measure Type: Number
Unit of Measure: participants
AEs 41 49 42 46
SAEs 3 9 8 5
Time Frame Baseline up to Week 38
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Hide Arm/Group Description Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks. Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
All-Cause Mortality
Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/62 (4.84%)   9/66 (13.64%)   8/62 (12.90%)   5/64 (7.81%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Cardiac disorders         
Acute myocardial infarction * 1  0/62 (0.00%)  0/66 (0.00%)  1/62 (1.61%)  0/64 (0.00%) 
Angina pectoris * 1  0/62 (0.00%)  0/66 (0.00%)  1/62 (1.61%)  0/64 (0.00%) 
Cardio-respiratory arrest * 1  0/62 (0.00%)  0/66 (0.00%)  1/62 (1.61%)  0/64 (0.00%) 
Right ventricular failure * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
Endocrine disorders         
Basedow's disease * 1  1/62 (1.61%)  0/66 (0.00%)  0/62 (0.00%)  0/64 (0.00%) 
Hyperthyroidism * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Gastrointestinal disorders         
Diverticular perforation * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Inguinal hernia * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
Intestinal obstruction * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
General disorders         
Non-cardiac chest pain * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Pyrexia * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Immune system disorders         
Drug hypersensitivity * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Infections and infestations         
Bronchitis * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
Pyopneumothorax * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
Relapsing fever * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Stenotrophomonas infection * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
Injury, poisoning and procedural complications         
Femur fracture * 1  1/62 (1.61%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Hip fracture * 1  0/62 (0.00%)  0/66 (0.00%)  2/62 (3.23%)  0/64 (0.00%) 
Humerus fracture * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Pelvic fracture * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Upper limb fracture * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Investigations         
Fibrin D dimer increased * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Musculoskeletal and connective tissue disorders         
Rheumatoid arthritis * 1  0/62 (0.00%)  2/66 (3.03%)  2/62 (3.23%)  0/64 (0.00%) 
Back pain * 1  1/62 (1.61%)  0/66 (0.00%)  0/62 (0.00%)  0/64 (0.00%) 
Osteonecrosis * 1  0/62 (0.00%)  0/66 (0.00%)  1/62 (1.61%)  0/64 (0.00%) 
Nervous system disorders         
Migraine * 1  1/62 (1.61%)  0/66 (0.00%)  0/62 (0.00%)  0/64 (0.00%) 
Vasculitis cerebral * 1  0/62 (0.00%)  0/66 (0.00%)  1/62 (1.61%)  0/64 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
Reproductive system and breast disorders         
Fallopian tube cyst * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  0/64 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism * 1  1/62 (1.61%)  0/66 (0.00%)  0/62 (0.00%)  0/64 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema * 1  0/62 (0.00%)  0/66 (0.00%)  1/62 (1.61%)  0/64 (0.00%) 
Surgical and medical procedures         
Prostatic operation * 1  0/62 (0.00%)  0/66 (0.00%)  0/62 (0.00%)  1/64 (1.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/62 (24.19%)   25/66 (37.88%)   16/62 (25.81%)   26/64 (40.63%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia * 1  0/62 (0.00%)  1/66 (1.52%)  0/62 (0.00%)  4/64 (6.25%) 
Gastrointestinal disorders         
Diarrhoea * 1  1/62 (1.61%)  4/66 (6.06%)  6/62 (9.68%)  5/64 (7.81%) 
Nausea * 1  1/62 (1.61%)  5/66 (7.58%)  4/62 (6.45%)  1/64 (1.56%) 
Constipation * 1  1/62 (1.61%)  4/66 (6.06%)  1/62 (1.61%)  2/64 (3.13%) 
Infections and infestations         
Upper respiratory tract infection * 1  4/62 (6.45%)  3/66 (4.55%)  0/62 (0.00%)  8/64 (12.50%) 
Urinary tract infection * 1  3/62 (4.84%)  4/66 (6.06%)  3/62 (4.84%)  5/64 (7.81%) 
Nasopharyngitis * 1  1/62 (1.61%)  3/66 (4.55%)  1/62 (1.61%)  4/64 (6.25%) 
Nervous system disorders         
Headache * 1  4/62 (6.45%)  12/66 (18.18%)  5/62 (8.06%)  3/64 (4.69%) 
Vascular disorders         
Hypertension * 1  5/62 (8.06%)  3/66 (4.55%)  3/62 (4.84%)  2/64 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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.
Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00430495    
Other Study ID Numbers: 27298
First Submitted: January 30, 2007
First Posted: February 2, 2007
Results First Submitted: January 19, 2016
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016