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Trial record 2 of 3 for:    Siliq | psoriatic arthritis

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-1)

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: NCT02029495
Recruitment Status : Terminated (Sponsor Decision)
First Posted : January 8, 2014
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: Placebo
Enrollment 478
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo
Hide Arm/Group Description

Administered via subcutaneous injections

210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection

140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection until week 24.

Placebo: Placebo administered via subcutaneous injection until week 24.

Period Title: Overall Study
Started 159 158 161
Completed 158 158 159
Not Completed 1 0 2
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo Total
Hide Arm/Group Description

Administered via subcutaneous injections

210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection

140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection until week 24.

Placebo: Placebo administered via subcutaneous injection until week 24.

Total of all reporting groups
Overall Number of Baseline Participants 159 158 161 478
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 161 participants 478 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
144
  90.6%
138
  87.3%
145
  90.1%
427
  89.3%
>=65 years
15
   9.4%
20
  12.7%
16
   9.9%
51
  10.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 158 participants 161 participants 478 participants
49.1  (12.24) 49.9  (12.80) 48.1  (11.79) 49  (12.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 161 participants 478 participants
Female
70
  44.0%
80
  50.6%
80
  49.7%
230
  48.1%
Male
89
  56.0%
78
  49.4%
81
  50.3%
248
  51.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 161 participants 478 participants
American Indian or Alaska Native
2
   1.3%
0
   0.0%
0
   0.0%
2
   0.4%
Asian
0
   0.0%
0
   0.0%
4
   2.5%
4
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
155
  97.5%
152
  96.2%
152
  94.4%
459
  96.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.3%
6
   3.8%
5
   3.1%
13
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 161 participants 478 participants
Russian Federation 22 22 27 71
Hungary 5 6 4 15
United States 35 37 35 107
United Kingdom 6 3 6 15
Switzerland 1 6 5 12
Spain 10 4 7 21
Greece 2 2 2 6
Canada 4 3 2 9
Czech Republic 2 8 9 19
Belgium 0 0 2 2
Poland 50 45 44 139
Italy 2 5 2 9
Mexico 5 3 4 12
Slovakia 5 5 5 15
France 4 2 2 8
Bulgaria 2 4 3 9
Estonia 4 3 2 9
1.Primary Outcome
Title American College of Rheumatology (ACR) 20 Response
Hide Description An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient’s assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo
Hide Arm/Group Description:

Administered via subcutaneous injections

210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection

140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection until week 24.

Placebo: Placebo administered via subcutaneous injection until week 24.

Overall Number of Participants Analyzed 121 118 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
21.8
(10.6 to 33.1)
36.5
(22.8 to 45.3)
2.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI)75
Hide Description PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo
Hide Arm/Group Description:

Administered via subcutaneous injections

210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection

140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection until week 24.

Placebo: Placebo administered via subcutaneous injection until week 24.

Overall Number of Participants Analyzed 61 72 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.3
(57.6 to 82.9)
55.6
(27.9 to 56.6)
0
(0 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo
Hide Arm/Group Description

Administered via subcutaneous injections

210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection

140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection

Administered via subcutaneous injection until week 24.

Placebo: Placebo administered via subcutaneous injection until week 24.

All-Cause Mortality
210 mg Brodalumab 140 mg Brodalumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
210 mg Brodalumab 140 mg Brodalumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/158 (6.33%)   5/158 (3.16%)   4/159 (2.52%) 
Eye disorders       
Lens Dislocation *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
General disorders       
Dizziness *  0/158 (0.00%)  1/158 (0.63%)  0/159 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis *  0/158 (0.00%)  1/158 (0.63%)  0/159 (0.00%) 
Infections and infestations       
Urosepsis *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Injury, poisoning and procedural complications       
Eye Injury *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Injury *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Iris Injury *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Keratorhexis *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Synovial Cyst *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Intervertebral Disc protusion *  0/158 (0.00%)  0/158 (0.00%)  1/159 (0.63%) 
Muscular Weakness *  0/158 (0.00%)  1/158 (0.63%)  0/159 (0.00%) 
Psoriatic Arthropathy *  0/158 (0.00%)  1/158 (0.63%)  1/159 (0.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squimos Cell Carcinoma of the Vulva *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Malignant Melanoma *  0/158 (0.00%)  0/158 (0.00%)  1/159 (0.63%) 
Psychiatric disorders       
Major Depression *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Depression *  0/158 (0.00%)  0/158 (0.00%)  1/159 (0.63%) 
Skin and subcutaneous tissue disorders       
Drug reaction with Eosinaphilia and Systematic symptoms *  0/158 (0.00%)  1/158 (0.63%)  0/159 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
210 mg Brodalumab 140 mg Brodalumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   84/158 (53.16%)   79/158 (50.00%)   71/159 (44.65%) 
Blood and lymphatic system disorders       
Anaemia *  5/158 (3.16%)  4/158 (2.53%)  1/159 (0.63%) 
Cardiac disorders       
Palpations *  0/158 (0.00%)  0/158 (0.00%)  2/159 (1.26%) 
Gastrointestinal disorders       
Diarrheoa *  2/158 (1.27%)  5/158 (3.16%)  3/159 (1.89%) 
General disorders       
fatigue *  1/158 (0.63%)  1/158 (0.63%)  2/159 (1.26%) 
Odema Peripheral *  1/158 (0.63%)  0/158 (0.00%)  2/159 (1.26%) 
Odema *  0/158 (0.00%)  0/158 (0.00%)  2/159 (1.26%) 
Infections and infestations       
Nasopharyngitis *  24/158 (15.19%)  28/158 (17.72%)  7/159 (4.40%) 
Upper Respiratory tract Infection *  9/158 (5.70%)  9/158 (5.70%)  8/159 (5.03%) 
bronchitis *  6/158 (3.80%)  5/158 (3.16%)  2/159 (1.26%) 
Sinusitis *  3/158 (1.90%)  3/158 (1.90%)  2/159 (1.26%) 
Rhinitis *  4/158 (2.53%)  0/158 (0.00%)  3/159 (1.89%) 
urinary Tract Infection *  2/158 (1.27%)  0/158 (0.00%)  3/159 (1.89%) 
Viral infection *  2/158 (1.27%)  0/158 (0.00%)  0/159 (0.00%) 
gastroenteritis *  1/158 (0.63%)  3/158 (1.90%)  1/159 (0.63%) 
Investigations       
Blood Pressure Increased *  2/158 (1.27%)  0/158 (0.00%)  0/159 (0.00%) 
Metabolism and nutrition disorders       
Gout *  0/158 (0.00%)  2/158 (1.27%)  0/159 (0.00%) 
Musculoskeletal and connective tissue disorders       
Psoriatic Arthropathy *  0/158 (0.00%)  3/158 (1.90%)  5/159 (3.14%) 
Spinal Pain *  0/158 (0.00%)  0/158 (0.00%)  2/159 (1.26%) 
Nervous system disorders       
Headache *  5/158 (3.16%)  4/158 (2.53%)  3/159 (1.89%) 
Headache *  5/158 (3.16%)  3/158 (1.90%)  3/159 (1.89%) 
Dizziness *  1/158 (0.63%)  2/158 (1.27%)  1/159 (0.63%) 
Psychiatric disorders       
insomnia *  1/158 (0.63%)  3/158 (1.90%)  1/159 (0.63%) 
Depression *  0/158 (0.00%)  0/158 (0.00%)  2/159 (1.26%) 
Depressed Mood *  0/158 (0.00%)  2/158 (1.27%)  0/159 (0.00%) 
Major Depression *  1/158 (0.63%)  0/158 (0.00%)  0/159 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
oropharyngeal Pain *  2/158 (1.27%)  1/158 (0.63%)  2/159 (1.26%) 
Cough *  1/158 (0.63%)  0/158 (0.00%)  2/159 (1.26%) 
Asthma *  0/158 (0.00%)  0/158 (0.00%)  3/159 (1.89%) 
Skin and subcutaneous tissue disorders       
Psoriasis *  1/158 (0.63%)  0/158 (0.00%)  5/159 (3.14%) 
Erythema *  2/158 (1.27%)  2/158 (1.27%)  1/159 (0.63%) 
Vascular disorders       
Hypertension *  10/158 (6.33%)  2/158 (1.27%)  3/159 (1.89%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Valeant Pharmaceuticals
Phone: 908
EMail: binu.alexander@valeant.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02029495     History of Changes
Other Study ID Numbers: 20090406
2013-003554-25 ( EudraCT Number )
First Submitted: January 6, 2014
First Posted: January 8, 2014
Results First Submitted: November 8, 2016
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017