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Trial record 1 of 1 for:    NCT00356408
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Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)

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: NCT00356408
Recruitment Status : Completed
First Posted : July 26, 2006
Results First Posted : May 25, 2011
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: Certolizumab pegol
Enrollment 106
Recruitment Details The study was started in January 2007 with recruitment occurring in the United States, Germany, and Canada. The study had last patient last visit in February of 2010.
Pre-assignment Details  
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
Period Title: Overall Study
Started 103 [1]
Completed 43
Not Completed 60
Reason Not Completed
Adverse Event             9
Lack of Efficacy             36
Lost to Follow-up             2
Withdrawal by Subject             6
Other: Principal investigator discretion             3
Other: Sponsor request             1
Other: Azathioprine stopped             1
Other: Failed to meet Inc/Exc criteria             1
Other: Subject chose commerical dosing             1
[1]
106 subjects enrolled, however only 103 were included in the Intent to Treat (ITT) population.
Arm/Group Title Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer Total
Hide Arm/Group Description Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059. CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059. Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). Total of all reporting groups
Overall Number of Baseline Participants 14 16 40 33 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 40 participants 33 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
16
 100.0%
39
  97.5%
32
  97.0%
101
  98.1%
>=65 years
0
   0.0%
0
   0.0%
1
   2.5%
1
   3.0%
2
   1.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 40 participants 33 participants 103 participants
44.00  (12.53) 39.31  (12.83) 38.44  (13.73) 41.38  (13.75) 40.27  (13.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 40 participants 33 participants 103 participants
Female
6
  42.9%
9
  56.3%
22
  55.0%
18
  54.5%
55
  53.4%
Male
8
  57.1%
7
  43.8%
18
  45.0%
15
  45.5%
48
  46.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 40 participants 33 participants 103 participants
United States 8 10 31 21 70
Canada 4 6 7 10 27
Germany 2 0 2 2 6
1.Primary Outcome
Title Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Hide Description Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
Time Frame During this study (maximum 122 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the the Intent to Treat (ITT) population are included in this analysis.
Arm/Group Title Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer
Hide Arm/Group Description:
Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
Overall Number of Participants Analyzed 14 16 40 33
Measure Type: Number
Unit of Measure: subjects
12 15 32 30
2.Secondary Outcome
Title Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
Hide Description Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.
Time Frame Week 34 in this study
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the the Intent to Treat (ITT) population are included in this analysis.
Arm/Group Title Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer
Hide Arm/Group Description:
Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
Overall Number of Participants Analyzed 14 16 40 33
Measure Type: Number
Unit of Measure: percentage of subjects
28.6 37.5 35.0 3.0
Time Frame Duration of the study, maximum of 122 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer CDP870 400 mg (Overall)
Hide Arm/Group Description Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059. CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059. Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
All-Cause Mortality
Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer CDP870 400 mg (Overall)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer CDP870 400 mg (Overall)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/14 (35.71%)      0/16 (0.00%)      6/40 (15.00%)      4/33 (12.12%)      15/103 (14.56%)    
Gastrointestinal disorders           
Crohn's Disease * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 3/40 (7.50%)  6 1/33 (3.03%)  1 5/103 (4.85%)  8
Small Intestinal Obstruction * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/33 (6.06%)  3 3/103 (2.91%)  4
Abdominal Pain * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Haemorrhoids * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/33 (0.00%)  0 1/103 (0.97%)  1
Intestinal Fistula * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Nausea * 1  1/14 (7.14%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  2
Rectal Haemorrhage * 1  1/14 (7.14%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  2
Vomiting * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Infections and infestations           
Sepsis * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Perianal Abscess * 1  2/14 (14.29%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  2
Bronchopulmonary Aspergillosis * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 1/103 (0.97%)  1
Abscess * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/33 (0.00%)  0 1/103 (0.97%)  1
Abdominal Abscess * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Injury, poisoning and procedural complications           
Anastomotic Leak * 1  1/14 (7.14%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  2
Gastrointestinal Stoma Complication * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Intentional Overdose * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Metabolism and nutrition disorders           
Anorexia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Dehydration * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Failure To Thrive * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Renal and urinary disorders           
Renal Failure * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Renal Failure Acute * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Respiratory, thoracic and mediastinal disorders           
Chronic Obstructive Pulmonary Disease * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 1/103 (0.97%)  1
Respiratory Failure * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo/Completer CDP870/Completer Placebo/Non-completer CDP870/Non-completer CDP870 400 mg (Overall)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/14 (78.57%)      15/16 (93.75%)      31/40 (77.50%)      27/33 (81.82%)      84/103 (81.55%)    
Blood and lymphatic system disorders           
Iron Deficiency Anaemia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 1/33 (3.03%)  1 4/103 (3.88%)  4
Anaemia * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 3/40 (7.50%)  3 0/33 (0.00%)  0 4/103 (3.88%)  4
Cardiac disorders           
Palpitations * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Ear and labyrinth disorders           
Ear Pain * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  3 0/33 (0.00%)  0 2/103 (1.94%)  3
Cerumen Impaction * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Gastrointestinal disorders           
Crohn's Disease * 1  1/14 (7.14%)  1 2/16 (12.50%)  2 8/40 (20.00%)  11 11/33 (33.33%)  13 22/103 (21.36%)  27
Nausea * 1  1/14 (7.14%)  1 2/16 (12.50%)  2 2/40 (5.00%)  2 6/33 (18.18%)  6 11/103 (10.68%)  11
Abdominal Pain * 1  2/14 (14.29%)  3 2/16 (12.50%)  2 2/40 (5.00%)  2 3/33 (9.09%)  4 9/103 (8.74%)  11
Diarrhoea * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 4/40 (10.00%)  4 3/33 (9.09%)  3 8/103 (7.77%)  8
Vomiting * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 3/40 (7.50%)  11 2/33 (6.06%)  3 7/103 (6.80%)  16
Abdominal Distension * 1  2/14 (14.29%)  2 1/16 (6.25%)  1 2/40 (5.00%)  2 1/33 (3.03%)  1 6/103 (5.83%)  6
Rectal Haemorrhage * 1  2/14 (14.29%)  3 2/16 (12.50%)  2 2/40 (5.00%)  3 0/33 (0.00%)  0 6/103 (5.83%)  8
Abdominal Pain Lower * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 3/40 (7.50%)  4 2/33 (6.06%)  3 5/103 (4.85%)  7
Abdominal Pain Upper * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 2/40 (5.00%)  2 2/33 (6.06%)  3 5/103 (4.85%)  6
Dyspepsia * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 2/40 (5.00%)  2 0/33 (0.00%)  0 4/103 (3.88%)  4
Toothache * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  2 2/33 (6.06%)  2 3/103 (2.91%)  4
Tooth Impacted * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 2/33 (6.06%)  2 3/103 (2.91%)  3
Flatulence * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 1/33 (3.03%)  1 3/103 (2.91%)  3
Haemorrhoids * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Food Poisoning * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Anal Fissure * 1  0/14 (0.00%)  0 2/16 (12.50%)  4 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  4
Proctalgia * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  2
Gastrointestinal Hypomotility * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Dental Discomfort * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
General disorders           
Pyrexia * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 4/40 (10.00%)  4 2/33 (6.06%)  3 8/103 (7.77%)  9
Fatigue * 1  1/14 (7.14%)  3 1/16 (6.25%)  1 2/40 (5.00%)  2 2/33 (6.06%)  2 6/103 (5.83%)  8
Oedema Peripheral * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 2/33 (6.06%)  2 4/103 (3.88%)  4
Influenza Like Illness * 1  1/14 (7.14%)  1 2/16 (12.50%)  2 1/40 (2.50%)  1 0/33 (0.00%)  0 4/103 (3.88%)  4
Chills * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 2/33 (6.06%)  2 3/103 (2.91%)  3
Injection Site Pain * 1  0/14 (0.00%)  0 1/16 (6.25%)  2 2/40 (5.00%)  3 0/33 (0.00%)  0 3/103 (2.91%)  5
Injection Site Irritation * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  2 0/33 (0.00%)  0 2/103 (1.94%)  3
Injection Site Erythema * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Immune system disorders           
Seasonal Allergy * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/33 (6.06%)  2 3/103 (2.91%)  3
Infections and infestations           
Upper Respiratory Tract Infection * 1  1/14 (7.14%)  1 2/16 (12.50%)  2 6/40 (15.00%)  7 5/33 (15.15%)  7 14/103 (13.59%)  17
Nasopharyngitis * 1  2/14 (14.29%)  2 0/16 (0.00%)  0 7/40 (17.50%)  9 3/33 (9.09%)  4 12/103 (11.65%)  15
Sinusitis * 1  1/14 (7.14%)  1 3/16 (18.75%)  4 5/40 (12.50%)  6 1/33 (3.03%)  1 10/103 (9.71%)  12
Urinary Tract Infection * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 4/40 (10.00%)  4 4/33 (12.12%)  5 8/103 (7.77%)  9
Influenza * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 4/40 (10.00%)  7 1/33 (3.03%)  1 7/103 (6.80%)  10
Gastroenteritis Viral * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 1/33 (3.03%)  1 4/103 (3.88%)  4
Herpes Simplex * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 3/33 (9.09%)  3 3/103 (2.91%)  3
Bronchitis * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 1/40 (2.50%)  1 0/33 (0.00%)  0 3/103 (2.91%)  3
Lower Respiratory Tract Infection * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Chronic Sinusitis * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Folliculitis * 1  0/14 (0.00%)  0 1/16 (6.25%)  4 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  4
Viral Infection * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Viral Upper Respiratory Tract Infection * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Abdominal Abscess * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Onychomycosis * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Injury, poisoning and procedural complications           
Epicondylitis * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Postoperative Ileus * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Exposure To Toxic Agent * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Meniscus Lesion * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Procedural Pain * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Investigations           
Heart Rate Increased * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 2/33 (6.06%)  2 2/103 (1.94%)  2
Blood Creatinine Abnormal * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Hepatic Enzyme Abnormal * 1  1/14 (7.14%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  2
Metabolism and nutrition disorders           
Vitamin D Deficiency * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/33 (3.03%)  1 3/103 (2.91%)  3
Hypoalbuminaemia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Hypokalaemia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Anorexia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Hyperglycaemia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Hypocalcaemia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/14 (0.00%)  0 4/16 (25.00%)  6 8/40 (20.00%)  11 7/33 (21.21%)  8 19/103 (18.45%)  25
Myalgia * 1  0/14 (0.00%)  0 3/16 (18.75%)  4 3/40 (7.50%)  3 1/33 (3.03%)  1 7/103 (6.80%)  8
Muscle Spasms * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 3/40 (7.50%)  4 0/33 (0.00%)  0 5/103 (4.85%)  6
Back Pain * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 2/33 (6.06%)  5 3/103 (2.91%)  6
Arthritis * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Muscular Weakness * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 0/33 (0.00%)  0 2/103 (1.94%)  2
Neck Pain * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Pain In Extremity * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  2
Shoulder Pain * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  2
Muscle Fatigue * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Arthropathy * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Uterine Leiomyoma * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Nervous system disorders           
Headache * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 5/40 (12.50%)  7 5/33 (15.15%)  6 11/103 (10.68%)  14
Dizziness * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 4/40 (10.00%)  4 3/33 (9.09%)  3 7/103 (6.80%)  7
Migraine * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 2/40 (5.00%)  3 2/33 (6.06%)  12 6/103 (5.83%)  17
Paraesthesia * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 1/40 (2.50%)  2 0/33 (0.00%)  0 2/103 (1.94%)  3
Hypoaesthesia * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Psychiatric disorders           
Depression * 1  1/14 (7.14%)  1 2/16 (12.50%)  2 2/40 (5.00%)  2 1/33 (3.03%)  1 6/103 (5.83%)  6
Insomnia * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 2/33 (6.06%)  2 4/103 (3.88%)  4
Stress * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 1/33 (3.03%)  1 3/103 (2.91%)  3
Nervousness * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Agitation * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Renal and urinary disorders           
Dysuria * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Oliguria * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Respiratory, thoracic and mediastinal disorders           
Pharyngolaryngeal Pain * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 4/40 (10.00%)  4 2/33 (6.06%)  2 6/103 (5.83%)  6
Cough * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 1/40 (2.50%)  1 0/33 (0.00%)  0 3/103 (2.91%)  3
Rhinorrhoea * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 0/33 (0.00%)  0 2/103 (1.94%)  2
Nasal Congestion * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Sinus Congestion * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  2 0/33 (0.00%)  0 2/103 (1.94%)  3
Epistaxis * 1  0/14 (0.00%)  0 2/16 (12.50%)  2 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  2
Skin and subcutaneous tissue disorders           
Rash * 1  2/14 (14.29%)  3 0/16 (0.00%)  0 1/40 (2.50%)  2 3/33 (9.09%)  4 6/103 (5.83%)  9
Erythema Nodosum * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/33 (3.03%)  1 2/103 (1.94%)  2
Night Sweats * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 0/33 (0.00%)  0 2/103 (1.94%)  2
Dry Skin * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 0/33 (0.00%)  0 2/103 (1.94%)  2
Pruritus * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 0/33 (0.00%)  0 2/103 (1.94%)  2
Vascular Skin Disorder * 1  1/14 (7.14%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/33 (0.00%)  0 1/103 (0.97%)  1
Vascular disorders           
Hypertension * 1  1/14 (7.14%)  1 1/16 (6.25%)  1 2/40 (5.00%)  2 2/33 (6.06%)  2 6/103 (5.83%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00356408    
Other Study ID Numbers: C87065
2006-003871-11 ( EudraCT Number )
First Submitted: July 25, 2006
First Posted: July 26, 2006
Results First Submitted: February 23, 2011
Results First Posted: May 25, 2011
Last Update Posted: August 9, 2018