Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (Visual II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01124838
First received: May 14, 2010
Last updated: May 13, 2016
Last verified: May 2016
Results First Received: May 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Uveitis
Interventions: Drug: Adalimumab
Drug: Prednisone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study includes a Japan sub-study. A total of 261 adults with inactive non-infectious intermediate uveitis, posterior uveitis or panuveitis were randomized at 72 study sites worldwide; 229 participants at 62 study sites in Australia, Israel, Latin America, North America, and Europe (Main Study), and 32 participants at 10 study sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Participants were randomized in a 1:1 ratio double-masked fashion using baseline immunosuppressant (IMM) usage as the stratification factor. Participants in the Japan sub-study were randomized in a separate stratum with no stratification by baseline IMM usage.

Study completion is defined as meeting treatment failure or reaching study Week 80.


Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Adalimumab Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.

Participant Flow:   Overall Study
    Placebo     Adalimumab  
STARTED     130     131  
Enrolled in Main Study     114     115  
Enrolled in Japan Sub-study     16     16  
COMPLETED     112     116  
NOT COMPLETED     18     15  
Miscellaneous                 4                 2  
Adverse Event                 7                 11  
Lack of Efficacy                 2                 0  
Withdrawal by Subject                 3                 2  
Lost to Follow-up                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Adalimumab Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Total Total of all reporting groups

Baseline Measures
    Placebo     Adalimumab     Total  
Number of Participants  
[units: participants]
  130     131     261  
Age  
[units: years]
Mean (Standard Deviation)
  43.22  (14.026)     43.18  (12.719)     43.20  (13.360)  
Age, Customized  
[units: participants]
     
< 65 years     121     125     246  
≥ 65 years     9     6     15  
Gender  
[units: participants]
     
Female     83     75     158  
Male     47     56     103  
Race/Ethnicity, Customized  
[units: participants]
     
White     96     96     192  
Black     8     6     14  
Asian     19     19     38  
American Indian/Alaskan Native     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Other     5     9     14  
Multi-Race     1     1     2  
Type of Uveitis  
[units: participants]
     
Intermediate     30     17     47  
Posterior     36     41     77  
Panuveitis     63     71     134  
Intermediate/Posterior     1     2     3  
Diagnosis  
[units: participants]
     
Idiopathic     45     33     78  
Birdshot Choroidopathy     16     15     31  
Multifocal Choroiditis and Panuveitis     2     5     7  
Vogt Koyanagi Harada     30     34     64  
Sarcoid     20     22     42  
Behcet's     7     10     17  
Other     10     12     22  
Eye Affected  
[units: participants]
     
Left     3     3     6  
Right     5     2     7  
Both     122     126     248  
History of Infectious Uveitis  
[units: participants]
     
Yes     0     0     0  
No     130     131     261  
Duration of Uveitis  
[units: months]
Mean (Standard Deviation)
  59.36  (64.753)     58.35  (61.834)     58.85  (63.185)  



  Outcome Measures
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1.  Primary:   Time to Treatment Failure on or After Week 2   [ Time Frame: From Baseline until end of study (up to 80 weeks) ]

2.  Secondary:   Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and at the Final/Early Termination Visit (up to 80 weeks) ]

3.  Secondary:   Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and Final/Early Termination Visit (up to 80 weeks) ]

4.  Secondary:   Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and Final/Early Termination Visit (up to 80 weeks) ]

5.  Secondary:   Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2   [ Time Frame: From Baseline until the Final Visit (up to 80 weeks) ]

6.  Secondary:   Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.   [ Time Frame: Baseline and Final/Early Termination Visit (up to 80 weeks) ]

7.  Secondary:   Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and Final/Early Termination Visit (up 80 weeks) ]

8.  Secondary:   Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and Final/Early Termination Visit (up 80 weeks) ]

9.  Secondary:   Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and Final/Early Termination Visit (up 80 weeks) ]

10.  Secondary:   Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit   [ Time Frame: Baseline and Final/Early Termination Visit (up 80 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01124838     History of Changes
Other Study ID Numbers: M10-880
2009-016008-22 ( EudraCT Number )
Study First Received: May 14, 2010
Results First Received: May 13, 2016
Last Updated: May 13, 2016
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic
Brazil: Ministry of Health
Mexico: Ministry of Health
Czech Republic: State Institute for Drug Control
Greece: Ministry of Health and Welfare
Argentina: Ministry of Health