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A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

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ClinicalTrials.gov Identifier: NCT00683930
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pemphigus Vulgaris (PV)
Interventions Drug: Mycophenolate Mofetil 2 g/Day
Drug: Mycophenolate Mofetil (MMF) 3 g/Day
Drug: Placebo
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo MMF 2 g/Day MMF 3 g/Day
Hide Arm/Group Description Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
Period Title: Overall Study
Started 36 [1] 21 [1] 37
Completed 29 18 28
Not Completed 7 3 9
[1]
One subject not included: no study drug dispensed.
Arm/Group Title Placebo MMF 2 g/Day MMF 3 g/Day Total
Hide Arm/Group Description Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks Total of all reporting groups
Overall Number of Baseline Participants 36 21 37 94
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 21 participants 37 participants 94 participants
45.8  (12.18) 41.0  (15.59) 44.8  (13.47) 44.33  (13.45)
[1]
Measure Description: Intent-to-treat population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 94 participants
Female
24
  66.7%
14
  66.7%
18
  48.6%
56
  59.6%
Male
12
  33.3%
7
  33.3%
19
  51.4%
38
  40.4%
[1]
Measure Description: Intent-to-treat population
1.Primary Outcome
Title Percentage of Patients Achieving Responder Status at Week 52
Hide Description The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.
Arm/Group Title Placebo MMF 2 g/Day and MMF 3 g/Day Groups Combined
Hide Arm/Group Description:
Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
Overall Number of Participants Analyzed 36 58
Measure Type: Number
Unit of Measure: Percentage of Participants
63.9 69.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MMF 2 g/Day and MMF 3 g/Day Groups Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6558
Comments [Not Specified]
Method Fisher Exact
Comments Alpha = 0.025
Method of Estimation Estimation Parameter Treatment difference in response rate
Estimated Value 5.1
Confidence Interval 97.5%
-17.4 to 27.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Initial Response
Hide Description Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.
Arm/Group Title Placebo MMF 2 g/Day and MMF 3 g/Day Groups Combined
Hide Arm/Group Description:
Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
Overall Number of Participants Analyzed 36 58
Median (Inter-Quartile Range)
Unit of Measure: Weeks
31.3
(25.0 to 36.4)
24.1
(20.3 to 32.4)
3.Secondary Outcome
Title Time to Sustained Response
Hide Description Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.
Arm/Group Title Placebo MMF 2 g/Day and MMF 3 g/Day Groups Combined
Hide Arm/Group Description:
Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
Overall Number of Participants Analyzed 16 35
Median (Full Range)
Unit of Measure: Weeks
46.0 [1] 
(29.7 to NA)
32.1 [1] 
(20.6 to NA)
[1]
Data not available. Median, Q1, and Q3 are calculated from Kaplan-Meier estimates.
4.Secondary Outcome
Title Duration of Prednisone Maintenance Dosing
Hide Description The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.
Arm/Group Title Placebo MMF 2 g/Day and MMF 3 g/Day Groups Combined Mycophenolate Mofetil 2 g/Day Mycophenolate Mofetil 3 g/Day
Hide Arm/Group Description:
Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
MMF 500 mg tablets; 6 tablets twice daily for 52 weeks
Overall Number of Participants Analyzed 36 58 21 37
Median (Inter-Quartile Range)
Unit of Measure: Days
136.5
(60.0 to 191.0)
186.0
(79.0 to 244.0)
185.0
(109.0 to 246.0)
187.0
(75.0 to 225.0)
Time Frame AEs were monitored throughout the course of the study. Further follow-up was made at approximately 24 weeks (±7 days) after the Week 52 visit to record any AEs that occurred during the follow-up period.
Adverse Event Reporting Description Safety analysis population. Note one patient from both the placebo group and MMF 2g/day group were excluded from the safety population as no study drug was dispensed.
 
Arm/Group Title Placebo MMF 2 g/Day MMF 3 g/Day
Hide Arm/Group Description Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
All-Cause Mortality
Placebo MMF 2 g/Day MMF 3 g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MMF 2 g/Day MMF 3 g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/36 (11.11%)   1/21 (4.76%)   3/37 (8.11%) 
Eye disorders       
Cataract  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders       
Food Poisoning  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Duodenal Ulcer  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Pancreatitis  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Infections and infestations       
Varicella  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders       
Osteonecrosis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Nervous system disorders       
Cerebrovascular Accident  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Abortion Spontaneous  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Skin and subcutaneous tissue disorders       
Pemphigus  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Vascular disorders       
Cardiovascular Insufficiency  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo MMF 2 g/Day MMF 3 g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/36 (86.11%)   20/21 (95.24%)   32/37 (86.49%) 
Blood and lymphatic system disorders       
Anaemia  1  3/36 (8.33%)  1/21 (4.76%)  1/37 (2.70%) 
Lymphopenia  1  1/36 (2.78%)  0/21 (0.00%)  2/37 (5.41%) 
Leukocytosis  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Neutropenia  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Thrombocythaemia  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Thrombocytopenia  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Cardiac disorders       
Tachycardia  1  1/36 (2.78%)  0/21 (0.00%)  2/37 (5.41%) 
Myocardial Infarction  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Palpitations  1  1/36 (2.78%)  1/21 (4.76%)  0/37 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Endocrine disorders       
Cushingoid  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Eye disorders       
Conjunctivitis  1  0/36 (0.00%)  1/21 (4.76%)  1/37 (2.70%) 
Vision Blurred  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Visual Disturbance  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Cataract  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Glaucoma  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Lacrimation Increased  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Abnormal Sensation in Eye  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders       
Nausea  1  0/36 (0.00%)  1/21 (4.76%)  4/37 (10.81%) 
Vomiting  1  1/36 (2.78%)  1/21 (4.76%)  1/37 (2.70%) 
Constipation  1  2/36 (5.56%)  2/21 (9.52%)  3/37 (8.11%) 
Gastrooesophageal Reflux Disease  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Diarrhoea  1  3/36 (8.33%)  1/21 (4.76%)  3/37 (8.11%) 
Abdominal Pain  1  3/36 (8.33%)  0/21 (0.00%)  2/37 (5.41%) 
Abdominal Pain Upper  1  2/36 (5.56%)  0/21 (0.00%)  2/37 (5.41%) 
Frequent Bowel Movements  1  0/36 (0.00%)  1/21 (4.76%)  1/37 (2.70%) 
Cheilitis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Lip Ulceration  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Oral Soft Tissue Disorder  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Aphthous Stomatitis  1  1/36 (2.78%)  1/21 (4.76%)  0/37 (0.00%) 
Mouth Ulceration  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Oral Mucosa Erosion  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Stomatitis  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Rectal Tenesmus  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Toothache  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Dyspepsia  1  2/36 (5.56%)  0/21 (0.00%)  1/37 (2.70%) 
Abdominal Distension  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Flatulence  1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%) 
Gastritis  1  2/36 (5.56%)  0/21 (0.00%)  1/37 (2.70%) 
Enteritis  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Stomach Discomfort  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Dysphagia  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Haemorrhoids  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Rectal Haemorrhage  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Dry Mouth  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Oral Pain  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Odynophagia  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Oral Discomfort  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Salivary Hypersecretion  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Anal Fissure  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Loose Tooth  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Gingivitis  1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%) 
Haematemesis  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
General disorders       
Pyrexia  1  3/36 (8.33%)  4/21 (19.05%)  3/37 (8.11%) 
Fatigue  1  0/36 (0.00%)  1/21 (4.76%)  2/37 (5.41%) 
Asthenia  1  1/36 (2.78%)  0/21 (0.00%)  2/37 (5.41%) 
Pain  1  0/36 (0.00%)  1/21 (4.76%)  2/37 (5.41%) 
Chest Pain  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Irritability  1  0/36 (0.00%)  1/21 (4.76%)  1/37 (2.70%) 
Influenza Like Illness  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Chest Discomfort  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Oedema Peripheral  1  0/36 (0.00%)  1/21 (4.76%)  1/37 (2.70%) 
Immune system disorders       
Allergy to Arthropod Bite  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Infections and infestations       
Nasopharyngitis  1  0/36 (0.00%)  4/21 (19.05%)  3/37 (8.11%) 
Upper Respiratory Tract Infection  1  1/36 (2.78%)  1/21 (4.76%)  5/37 (13.51%) 
Rhinitis  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Laryngitis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Pharyngitis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Sinusitis  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Tonsillitis  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Oral Candidiasis  1  2/36 (5.56%)  1/21 (4.76%)  9/37 (24.32%) 
Candidiasis  1  2/36 (5.56%)  1/21 (4.76%)  1/37 (2.70%) 
Skin Candida  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Skin Infection  1  1/36 (2.78%)  2/21 (9.52%)  1/37 (2.70%) 
Furuncle  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Paronychia  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Pyoderma  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Subcutaneous Abscess  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Bronchitis  1  0/36 (0.00%)  1/21 (4.76%)  1/37 (2.70%) 
Bronchitis Acute  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Lower Respiratory Tract Infection  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Pneumonia  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Pneumonia Primary Atypical  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Urinary Tract Infection  1  2/36 (5.56%)  0/21 (0.00%)  4/37 (10.81%) 
Cystitis  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Pyelonephritis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Urethritis  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Herpes Simplex  1  1/36 (2.78%)  2/21 (9.52%)  2/37 (5.41%) 
Herpetic Gingivostomatitis  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Herpes Zoster  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Folliculitis  1  1/36 (2.78%)  0/21 (0.00%)  2/37 (5.41%) 
Bacteriuria  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Bacterial Infection  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Tinea Versicolour  1  0/36 (0.00%)  1/21 (4.76%)  2/37 (5.41%) 
Body Tinea  1  2/36 (5.56%)  0/21 (0.00%)  1/37 (2.70%) 
Viral Infection  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Bronchitis Viral  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Gastroenteritis Viral  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Gastroenteritis  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Dysentery  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Tooth Abscess  1  1/36 (2.78%)  1/21 (4.76%)  0/37 (0.00%) 
Fungal Skin Infection  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Infection  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Respiratory Tract Infection  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Influenza  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Molluscum Contagiosum  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Anogenital Warts  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Arthropod Bite  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Wound  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Arthropod Sting  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Contusion  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Skin Laceration  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Ear Abrasion  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Rib Fracture  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Joint Sprain  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Investigations       
Weight Increased  1  1/36 (2.78%)  0/21 (0.00%)  3/37 (8.11%) 
Weight Decreased  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Blood Glucose Increased  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Electrocardiogram ST-T Change  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Culture Urine Positive  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Sputum Culture Positive  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Intraocular Pressure Increased  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
White Blood Cells Urine  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders       
Central Obesity  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Diabetes Mellitus  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Hyperglycaemia  1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%) 
Hyperlipidaemia  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Iron Deficiency  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  2/36 (5.56%)  1/21 (4.76%)  3/37 (8.11%) 
Flank Pain  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Musculoskeletal Chest Pain  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Musculoskeletal Pain  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Pain In Extremity  1  1/36 (2.78%)  1/21 (4.76%)  0/37 (0.00%) 
Sensation of Heaviness  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Arthralgia  1  1/36 (2.78%)  3/21 (14.29%)  2/37 (5.41%) 
Joint Stiffness  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Muscle Spasms  1  0/36 (0.00%)  0/21 (0.00%)  3/37 (8.11%) 
Muscle Twitching  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Myalgia  1  1/36 (2.78%)  1/21 (4.76%)  1/37 (2.70%) 
Bone Pain  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Muscular Weakness  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Myopathy  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Myopathy Steroid  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Spinal Column Stenosis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Osteoporosis  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Muscle Rigidity  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin Papilloma  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Nervous system disorders       
Headache  1  1/36 (2.78%)  1/21 (4.76%)  6/37 (16.22%) 
Dysgeusia  1  0/36 (0.00%)  2/21 (9.52%)  2/37 (5.41%) 
Lethargy  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Somnolence  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Migraine  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Migraine With Aura  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Dizziness  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Hypoaesthesia  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Post Herpetic Neuralgia  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Tremor  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Dyskinesia  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Psychiatric disorders       
Depression  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Insomnia  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Libido Decreased  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Sleep Disorder  1  1/36 (2.78%)  1/21 (4.76%)  0/37 (0.00%) 
Nervousness  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Depressed Mood  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Renal and urinary disorders       
Dysuria  1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%) 
Pollakiuria  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Reproductive system and breast disorders       
Amenorrhoea  1  0/36 (0.00%)  2/21 (9.52%)  0/37 (0.00%) 
Metrorrhagia  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Polymenorrhoea  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Erectile Dysfunction  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Benign Prostatic Hyperplasia  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Perineal Pain  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Vaginal Erosion  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/36 (5.56%)  3/21 (14.29%)  3/37 (8.11%) 
Productive Cough  1  1/36 (2.78%)  0/21 (0.00%)  2/37 (5.41%) 
Dysphonia  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Pharyngolaryngeal Pain  1  3/36 (8.33%)  0/21 (0.00%)  1/37 (2.70%) 
Dyspnoea  1  2/36 (5.56%)  1/21 (4.76%)  0/37 (0.00%) 
Dyspnoea Exertional  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Bronchial Hyperreactivity  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Wheezing  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Lung Infiltration  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Skin and subcutaneous tissue disorders       
Pemphigus  1  12/36 (33.33%)  7/21 (33.33%)  10/37 (27.03%) 
Blister  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Acne  1  1/36 (2.78%)  0/21 (0.00%)  4/37 (10.81%) 
Dermatitis Acneiform  1  1/36 (2.78%)  0/21 (0.00%)  1/37 (2.70%) 
Pruritus  1  1/36 (2.78%)  2/21 (9.52%)  1/37 (2.70%) 
Rash Pruritic  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Pruritus Generalised  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Alopecia  1  2/36 (5.56%)  1/21 (4.76%)  1/37 (2.70%) 
Alopecia Effluvium  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Heat Rash  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Hyperhidrosis  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Swelling Face  1  3/36 (8.33%)  1/21 (4.76%)  1/37 (2.70%) 
Skin Lesion  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Ecchymosis  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Petechiae  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Purpura  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Purpura Senile  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Skin Ulcer  1  0/36 (0.00%)  1/21 (4.76%)  1/37 (2.70%) 
Erythema  1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%) 
Skin Hyperpigmentation  1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%) 
Rash  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Vascular disorders       
Hypertension  1  4/36 (11.11%)  3/21 (14.29%)  3/37 (8.11%) 
Venous Thrombosis  1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00683930     History of Changes
Obsolete Identifiers: NCT00140127
Other Study ID Numbers: WX17796
First Submitted: May 19, 2008
First Posted: May 26, 2008
Results First Submitted: November 18, 2009
Results First Posted: June 22, 2011
Last Update Posted: June 22, 2011