A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00683930
Collaborator
Aspreva Pharmaceuticals (Industry)
96
26
3
53
3.7
0.1
Study Details
Study Description
Brief Summary
This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipated time on study treatment was 12 months, and the target sample size was <100 individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris
Study Start Date
:
May 1, 2004
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
Oct 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mycophenolate Mofetil (MMF) 2 g/Day Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks |
Drug: Mycophenolate Mofetil 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
|
| Experimental: Mycophenolate Mofetil (MMF) 3 g/Day Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks |
Drug: Mycophenolate Mofetil (MMF) 3 g/Day
Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
|
| Placebo Comparator: Placebo
|
Drug: Placebo
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
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients Achieving Responder Status at Week 52 [52 weeks]
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
Secondary Outcome Measures
- Time to Initial Response [up to 52 weeks]
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 to Sustained Response [up to 52 weeks]
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.
- Duration of Prednisone Maintenance Dosing [52 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adult patients 18 to 70 years of age
-
Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
Exclusion Criteria:
-
Female patients who are pregnant, breastfeeding, or lactating
-
Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
-
CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
-
Use of PV therapies other than those noted above, within 4 weeks prior to randomization
-
Use of topical corticosteroids within 2 weeks prior to randomization
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Los Angeles | California | United States | 90095 | |
| 2 | Atlanta | Georgia | United States | 30033 | |
| 3 | Baltimore | Maryland | United States | 21205 | |
| 4 | St Louis | Missouri | United States | 63110 | |
| 5 | New York | New York | United States | 10010 | |
| 6 | Toronto | Ontario | Canada | M5T 3A9 | |
| 7 | Montreal | Quebec | Canada | H3G 1C6 | |
| 8 | Frankfurt Am Main | Germany | 60596 | ||
| 9 | Heidelberg | Germany | 69115 | ||
| 10 | Köln | Germany | 50937 | ||
| 11 | Mainz | Germany | 55131 | ||
| 12 | Münster | Germany | 48149 | ||
| 13 | ULM | Germany | 89081 | ||
| 14 | Haifa | Israel | 31096 | ||
| 15 | Petach Tikva | Israel | 49100 | ||
| 16 | Zürich | Switzerland | 8091 | ||
| 17 | Ankara | Turkey | 6100 | ||
| 18 | Ankara | Turkey | |||
| 19 | Istanbul | Turkey | |||
| 20 | Crimea | Ukraine | 95006 | ||
| 21 | Donetsk | Ukraine | 83099 | ||
| 22 | Kiev | Ukraine | 252151 | ||
| 23 | Lugnansk | Ukraine | |||
| 24 | Uzhgorod | Ukraine | 88011 | ||
| 25 | Leicester | United Kingdom | LE1 5WW | ||
| 26 | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Hoffmann-La Roche
- Aspreva Pharmaceuticals
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00683930
Other Study ID Numbers:
- WX17796
- NCT00140127
First Posted:
May 26, 2008
Last Update Posted:
Jun 22, 2011
Last Verified:
May 1, 2011
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | MMF 2 g/Day | MMF 3 g/Day |
|---|---|---|---|
| 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 | 21 | 37 |
| COMPLETED | 29 | 18 | 28 |
| NOT COMPLETED | 7 | 3 | 9 |
Baseline Characteristics
| Arm/Group Title | Placebo | MMF 2 g/Day | MMF 3 g/Day | Total |
|---|---|---|---|---|
| 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 Participants | 36 | 21 | 37 | 94 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
45.8
(12.18)
|
41.0
(15.59)
|
44.8
(13.47)
|
44.33
(13.45)
|
| Sex: Female, Male (Count of 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%
|
Outcome Measures
| Title | Percentage of Patients Achieving Responder Status at Week 52 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 36 | 58 |
| Number [Percentage of Participants] |
63.9
177.5%
|
69.0
328.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MMF 2 g/Day and MMF 3 g/Day Groups Combined |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6558 |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Initial Response |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 36 | 58 |
| Median (Inter-Quartile Range) [Weeks] |
31.3
|
24.1
|
| Title | Time to Sustained Response |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 16 | 35 |
| Median (Full Range) [Weeks] |
46.0
|
32.1
|
| Title | Duration of Prednisone Maintenance Dosing |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 36 | 58 | 21 | 37 |
| Median (Inter-Quartile Range) [Days] |
136.5
|
186.0
|
185.0
|
187.0
|
Adverse Events
| 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 | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Placebo | MMF 2 g/Day | MMF 3 g/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/36 (11.1%) | 1/21 (4.8%) | 3/37 (8.1%) | |||
| Eye disorders | ||||||
| Cataract | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Gastrointestinal disorders | ||||||
| Food Poisoning | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Duodenal Ulcer | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Pancreatitis | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Infections and infestations | ||||||
| Varicella | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Osteonecrosis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Nervous system disorders | ||||||
| Cerebrovascular Accident | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Pregnancy, puerperium and perinatal conditions | ||||||
| Pregnancy | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Abortion Spontaneous | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pemphigus | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Vascular disorders | ||||||
| Cardiovascular Insufficiency | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | MMF 2 g/Day | MMF 3 g/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/36 (86.1%) | 20/21 (95.2%) | 32/37 (86.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 3/36 (8.3%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Lymphopenia | 1/36 (2.8%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Leukocytosis | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Neutropenia | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Thrombocythaemia | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Thrombocytopenia | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Cardiac disorders | ||||||
| Tachycardia | 1/36 (2.8%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Myocardial Infarction | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Palpitations | 1/36 (2.8%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Endocrine disorders | ||||||
| Cushingoid | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Eye disorders | ||||||
| Conjunctivitis | 0/36 (0%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Vision Blurred | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Visual Disturbance | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Cataract | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Glaucoma | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Lacrimation Increased | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Abnormal Sensation in Eye | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 0/36 (0%) | 1/21 (4.8%) | 4/37 (10.8%) | |||
| Vomiting | 1/36 (2.8%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Constipation | 2/36 (5.6%) | 2/21 (9.5%) | 3/37 (8.1%) | |||
| Gastrooesophageal Reflux Disease | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Diarrhoea | 3/36 (8.3%) | 1/21 (4.8%) | 3/37 (8.1%) | |||
| Abdominal Pain | 3/36 (8.3%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Abdominal Pain Upper | 2/36 (5.6%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Frequent Bowel Movements | 0/36 (0%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Cheilitis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Lip Ulceration | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Oral Soft Tissue Disorder | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Aphthous Stomatitis | 1/36 (2.8%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Mouth Ulceration | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Oral Mucosa Erosion | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Stomatitis | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Rectal Tenesmus | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Toothache | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Dyspepsia | 2/36 (5.6%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Abdominal Distension | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Flatulence | 2/36 (5.6%) | 0/21 (0%) | 0/37 (0%) | |||
| Gastritis | 2/36 (5.6%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Enteritis | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Stomach Discomfort | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Dysphagia | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Haemorrhoids | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Rectal Haemorrhage | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Dry Mouth | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Oral Pain | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Odynophagia | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Oral Discomfort | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Salivary Hypersecretion | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Anal Fissure | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Loose Tooth | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Gingivitis | 2/36 (5.6%) | 0/21 (0%) | 0/37 (0%) | |||
| Haematemesis | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| General disorders | ||||||
| Pyrexia | 3/36 (8.3%) | 4/21 (19%) | 3/37 (8.1%) | |||
| Fatigue | 0/36 (0%) | 1/21 (4.8%) | 2/37 (5.4%) | |||
| Asthenia | 1/36 (2.8%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Pain | 0/36 (0%) | 1/21 (4.8%) | 2/37 (5.4%) | |||
| Chest Pain | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Irritability | 0/36 (0%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Influenza Like Illness | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Chest Discomfort | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Oedema Peripheral | 0/36 (0%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Immune system disorders | ||||||
| Allergy to Arthropod Bite | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 0/36 (0%) | 4/21 (19%) | 3/37 (8.1%) | |||
| Upper Respiratory Tract Infection | 1/36 (2.8%) | 1/21 (4.8%) | 5/37 (13.5%) | |||
| Rhinitis | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Laryngitis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pharyngitis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Sinusitis | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Tonsillitis | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Oral Candidiasis | 2/36 (5.6%) | 1/21 (4.8%) | 9/37 (24.3%) | |||
| Candidiasis | 2/36 (5.6%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Skin Candida | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Skin Infection | 1/36 (2.8%) | 2/21 (9.5%) | 1/37 (2.7%) | |||
| Furuncle | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Paronychia | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pyoderma | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Subcutaneous Abscess | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Bronchitis | 0/36 (0%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Bronchitis Acute | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Lower Respiratory Tract Infection | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pneumonia | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Pneumonia Primary Atypical | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Urinary Tract Infection | 2/36 (5.6%) | 0/21 (0%) | 4/37 (10.8%) | |||
| Cystitis | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Pyelonephritis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Urethritis | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Herpes Simplex | 1/36 (2.8%) | 2/21 (9.5%) | 2/37 (5.4%) | |||
| Herpetic Gingivostomatitis | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Herpes Zoster | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Folliculitis | 1/36 (2.8%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Bacteriuria | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Bacterial Infection | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Tinea Versicolour | 0/36 (0%) | 1/21 (4.8%) | 2/37 (5.4%) | |||
| Body Tinea | 2/36 (5.6%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Viral Infection | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Bronchitis Viral | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Gastroenteritis Viral | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Gastroenteritis | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Dysentery | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Tooth Abscess | 1/36 (2.8%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Fungal Skin Infection | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Infection | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Respiratory Tract Infection | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Influenza | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Molluscum Contagiosum | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Anogenital Warts | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fall | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Arthropod Bite | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Wound | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Arthropod Sting | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Contusion | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Skin Laceration | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Ear Abrasion | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Rib Fracture | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Joint Sprain | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Investigations | ||||||
| Weight Increased | 1/36 (2.8%) | 0/21 (0%) | 3/37 (8.1%) | |||
| Weight Decreased | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Blood Glucose Increased | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Electrocardiogram ST-T Change | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Culture Urine Positive | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Sputum Culture Positive | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Intraocular Pressure Increased | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| White Blood Cells Urine | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Central Obesity | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Diabetes Mellitus | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Hyperglycaemia | 2/36 (5.6%) | 0/21 (0%) | 0/37 (0%) | |||
| Hyperlipidaemia | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Iron Deficiency | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back Pain | 2/36 (5.6%) | 1/21 (4.8%) | 3/37 (8.1%) | |||
| Flank Pain | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Musculoskeletal Chest Pain | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Musculoskeletal Pain | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pain In Extremity | 1/36 (2.8%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Sensation of Heaviness | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Arthralgia | 1/36 (2.8%) | 3/21 (14.3%) | 2/37 (5.4%) | |||
| Joint Stiffness | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Muscle Spasms | 0/36 (0%) | 0/21 (0%) | 3/37 (8.1%) | |||
| Muscle Twitching | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Myalgia | 1/36 (2.8%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Bone Pain | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Muscular Weakness | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Myopathy | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Myopathy Steroid | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Spinal Column Stenosis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Osteoporosis | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Muscle Rigidity | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Skin Papilloma | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Nervous system disorders | ||||||
| Headache | 1/36 (2.8%) | 1/21 (4.8%) | 6/37 (16.2%) | |||
| Dysgeusia | 0/36 (0%) | 2/21 (9.5%) | 2/37 (5.4%) | |||
| Lethargy | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Somnolence | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Migraine | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Migraine With Aura | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Dizziness | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Hypoaesthesia | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Post Herpetic Neuralgia | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Tremor | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Dyskinesia | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Psychiatric disorders | ||||||
| Depression | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Insomnia | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Libido Decreased | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Sleep Disorder | 1/36 (2.8%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Nervousness | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Depressed Mood | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 0/36 (0%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Pollakiuria | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Reproductive system and breast disorders | ||||||
| Amenorrhoea | 0/36 (0%) | 2/21 (9.5%) | 0/37 (0%) | |||
| Metrorrhagia | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Polymenorrhoea | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Erectile Dysfunction | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Benign Prostatic Hyperplasia | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Perineal Pain | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Vaginal Erosion | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 2/36 (5.6%) | 3/21 (14.3%) | 3/37 (8.1%) | |||
| Productive Cough | 1/36 (2.8%) | 0/21 (0%) | 2/37 (5.4%) | |||
| Dysphonia | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pharyngolaryngeal Pain | 3/36 (8.3%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Dyspnoea | 2/36 (5.6%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Dyspnoea Exertional | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Bronchial Hyperreactivity | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Wheezing | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Lung Infiltration | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pemphigus | 12/36 (33.3%) | 7/21 (33.3%) | 10/37 (27%) | |||
| Blister | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Acne | 1/36 (2.8%) | 0/21 (0%) | 4/37 (10.8%) | |||
| Dermatitis Acneiform | 1/36 (2.8%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pruritus | 1/36 (2.8%) | 2/21 (9.5%) | 1/37 (2.7%) | |||
| Rash Pruritic | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Pruritus Generalised | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Alopecia | 2/36 (5.6%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Alopecia Effluvium | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Heat Rash | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Hyperhidrosis | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Swelling Face | 3/36 (8.3%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Skin Lesion | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Ecchymosis | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Petechiae | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Purpura | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Purpura Senile | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Skin Ulcer | 0/36 (0%) | 1/21 (4.8%) | 1/37 (2.7%) | |||
| Erythema | 0/36 (0%) | 1/21 (4.8%) | 0/37 (0%) | |||
| Skin Hyperpigmentation | 0/36 (0%) | 0/21 (0%) | 1/37 (2.7%) | |||
| Rash | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
| Vascular disorders | ||||||
| Hypertension | 4/36 (11.1%) | 3/21 (14.3%) | 3/37 (8.1%) | |||
| Venous Thrombosis | 1/36 (2.8%) | 0/21 (0%) | 0/37 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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:
,
,
ClinicalTrials.gov Identifier:
NCT00683930
Other Study ID Numbers:
- WX17796
- NCT00140127
First Posted:
May 26, 2008
Last Update Posted:
Jun 22, 2011
Last Verified:
May 1, 2011