A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis (VISUAL III)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01148225
First received: May 14, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

There is an unmet medical need in non-infectious intermediate-, posterior- and pan uveitis. These types of uveitis are at a higher risk for vision loss compared to anterior uveitis. Patients with these types of uveitis are often treated with chronic corticosteroids. The use of chronic corticosteroids is linked with predictable long-term side effects. The objective of this study is to evaluate the long term efficacy and safety of adalimumab subjects with non-infectious intermediate-, posterior- or pan-uveitis.


Condition Intervention Phase
Uveitis
Drug: adalimumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Evaluation of Adverse Events [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: Yes ]
  • Significant laboratory value changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: Yes ]
  • Significant vital sign changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point with a Grade <= 0.5+ in AC cells in both eyes on Slit Lamp Exam according to SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point with a Grade <= 0.5+ in vitreous haze in both eyes on indirect ophthalmoscopy according to NEI/SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point without a worsening of BCVA by >= 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point without a worsening of BCVA by >= 15 letters on the ETDRS in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Percent change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Percent change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
adalimumab

This study is a Phase 3, open-label multicenter study designed to evaluate long-term safety and efficacy of adalimumab in adult subjects with non-infectious intermediate-, posterior-, or pan-uveitis who have either discontinued from study M10-877 or M10-880 for having met "Treatment Failure" criteria or have successfully completed study M10-877 or M10-880.

Starting at Baseline, all subjects will receive open label adalimumab 40 mg eow SC regardless of treatment assignment in the randomized, double-masked studies M10-877 or M10-880.

Drug: adalimumab
This study is a Phase 3, open-label multicenter study designed to evaluate long-term safety and efficacy of adalimumab in adult subjects with non-infectious intermediate-, posterior-, or pan-uveitis who have either discontinued from study M10-877 or M10-880 for having met "Treatment Failure" criteria or have successfully completed study M10-877 or M10-880.
Other Name: ABT-D2E7 Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully enrolled in either study M10-877 or M10-880 and either met the endpoint of "Treatment Failure" or completed the study

Exclusion Criteria:

  • A subject will be excluded from this study if the patient discontinued from study M10-877 or M10-880 for any reasons other than having a Treatment Failure event
  • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
  • Subjects with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications or evidence of glaucomatous optic nerve injury
  • Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
  • Subject with neovascular/wet age-related macular degeneration
  • Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
  • Subject with a systemic inflammatory disease that requires therapy with a prohibited immunosuppressive agent at the time of study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148225

  Hide Study Locations
Locations
United States, California
Site Reference ID/Investigator# 49744
Beverly Hills, California, United States, 90211
United States, Florida
Site Reference ID/Investigator# 27869
Miami, Florida, United States, 33143
Site Reference ID/Investigator# 58303
Tamarac, Florida, United States, 33321
Site Reference ID/Investigator# 26184
Tampa, Florida, United States, 33603
United States, Georgia
Site Reference ID/Investigator# 25651
Atlanta, Georgia, United States, 30322
United States, Illinois
Site Reference ID/Investigator# 86513
Chicago, Illinois, United States, 60611
Site Reference ID/Investigator# 25642
Chicago, Illinois, United States, 60612
United States, Maine
Site Reference ID/Investigator# 37133
Ellsworth, Maine, United States, 04605
United States, Maryland
Site Reference ID/Investigator# 25643
Baltimore, Maryland, United States, 21287
Site Reference ID/Investigator# 75445
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Site Reference ID/Investigator# 65693
Boston, Massachusetts, United States, 02114
United States, Michigan
Site Reference ID/Investigator# 25645
Detroit, Michigan, United States, 48201
United States, New Jersey
Site Reference ID/Investigator# 25630
Palisades Park, New Jersey, United States, 07650
United States, New York
Site Reference ID/Investigator# 25635
New York, New York, United States, 10003
Site Reference ID/Investigator# 69838
New York, New York, United States, 10029
Site Reference ID/Investigator# 108339
New York, New York, United States, 10021
United States, North Carolina
Site Reference ID/Investigator# 26725
Durham, North Carolina, United States, 27705
Site Reference ID/Investigator# 63245
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Site Reference ID/Investigator# 25652
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Site Reference ID/Investigator# 25653
Portland, Oregon, United States, 97239
United States, Texas
Site Reference ID/Investigator# 27404
Dallas, Texas, United States, 75231
Site Reference ID/Investigator# 25637
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 25657
Houston, Texas, United States, 77025
Site Reference ID/Investigator# 81175
McAllen, Texas, United States, 78503
Site Reference ID/Investigator# 25648
San Antonio, Texas, United States, 78240
Site Reference ID/Investigator# 93195
Temple, Texas, United States, 76508
United States, Utah
Site Reference ID/Investigator# 25656
Salt Lake City, Utah, United States, 84132
United States, Virginia
Site Reference ID/Investigator# 25649
Norfolk, Virginia, United States, 23502
United States, West Virginia
Site Reference ID/Investigator# 97497
Morgantown, West Virginia, United States, 26506
Argentina
Site Reference ID/Investigator# 75259
Buenos Aires, Argentina, C1120AAN
Site Reference ID/Investigator# 71313
Buenos Aires, Argentina, B1629ODT
Site Reference ID/Investigator# 71296
Buenos Aires, Argentina, C1015ABO
Site Reference ID/Investigator# 75260
Rosario, Argentina, S2000DFA
Australia
Site Reference ID/Investigator# 25846
East Melbourne, Australia, 3002
Site Reference ID/Investigator# 25848
Perth, Australia, 6009
Austria
Site Reference ID/Investigator# 25849
Vienna, Austria, 1030
Belgium
Site Reference ID/Investigator# 25853
Ghent, Belgium, 9000
Site Reference ID/Investigator# 25854
Leuven, Belgium, 3000
Brazil
Site Reference ID/Investigator# 72755
Rio de Janeiro, Brazil, 21941-913
Site Reference ID/Investigator# 76455
Sao Paulo, Brazil, 04023-062
Canada
Site Reference ID/Investigator# 26024
Calgary, Canada, T2H 0C8
Site Reference ID/Investigator# 26023
London, Canada, N6A 4V2
Site Reference ID/Investigator# 26019
Montreal, Canada, H3A 1A1
Site Reference ID/Investigator# 26018
Montreal, Canada, H1T 2M4
Site Reference ID/Investigator# 47400
Ottawa, Canada, K1H 8L6
Site Reference ID/Investigator# 77944
Vancouver, Canada, V5Z 3N9
Site Reference ID/Investigator# 82675
Vancouver, Canada, V6Z 1Y6
Czech Republic
Site Reference ID/Investigator# 25856
Prague 2, Czech Republic, 128 00
Denmark
Site Reference ID/Investigator# 25858
Aarhus, Denmark, 8000
Site Reference ID/Investigator# 25857
Glostrup, Denmark, 2600
France
Site Reference ID/Investigator# 25866
Nantes Cedex 1, France, 44093
Site Reference ID/Investigator# 97937
Paris, France, 75012
Site Reference ID/Investigator# 25860
Paris Cedex 14, France, 75679
Germany
Site Reference ID/Investigator# 25869
Freiburg, Germany, 79106
Site Reference ID/Investigator# 25868
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 76755
Kiel, Germany, 24105
Site Reference ID/Investigator# 25867
Muenster, Germany, 48145
Site Reference ID/Investigator# 72278
Munich, Germany, 80336
Greece
Site Reference ID/Investigator# 74641
Thessaloniki, Greece, 57001
Israel
Site Reference ID/Investigator# 25873
Petach Tiqwa, Israel, 49100
Site Reference ID/Investigator# 25876
Tel Aviv, Israel, 64239
Italy
Site Reference ID/Investigator# 78355
Bologna, Italy, 40138
Site Reference ID/Investigator# 25879
Milan, Italy, 20132
Site Reference ID/Investigator# 47964
Negrar (Verona), Italy, 37024
Site Reference ID/Investigator# 71855
Reggio Emilia, Italy, 42100
Site Reference ID/Investigator# 25878
Rome, Italy, 00161
Japan
Site Reference ID/Investigator# 26345
Fukuoka-shi, Japan
Site Reference ID/Investigator# 88039
Nagakute-shi, Japan
Site Reference ID/Investigator# 26338
Sapporo-shi, Japan
Site Reference ID/Investigator# 29753
Sendai-shi, Japan
Site Reference ID/Investigator# 26344
Suita-shi, Japan
Site Reference ID/Investigator# 26340
Tokyo, Japan
Site Reference ID/Investigator# 26339
Tokyo, Japan
Site Reference ID/Investigator# 88040
Tokyo, Japan
Site Reference ID/Investigator# 26341
Tokyo, Japan
Site Reference ID/Investigator# 88041
Ube-shi, Japan
Site Reference ID/Investigator# 26343
Yokohama-shi, Japan
Mexico
Site Reference ID/Investigator# 71555
Mexico DF, Mexico, 04030
Site Reference ID/Investigator# 71295
Tijuana, Mexico, 22320
Poland
Site Reference ID/Investigator# 74815
Gdansk-Chelm, Poland, 80-809
Site Reference ID/Investigator# 74818
Wroclaw, Poland, 50-556
Portugal
Site Reference ID/Investigator# 25883
Coimbra, Portugal, 3000-075
Spain
Site Reference ID/Investigator# 25884
Barcelona, Spain, 08028
Site Reference ID/Investigator# 25887
Valencia, Spain, 46014
Site Reference ID/Investigator# 25890
Valladolid, Spain, 47011
Switzerland
Site Reference ID/Investigator# 75615
Bern, Switzerland, 3012
Site Reference ID/Investigator# 75235
Lausanne, Switzerland, 1004
United Kingdom
Site Reference ID/Investigator# 25895
Aberdeen, United Kingdom, AB25 2ZD
Site Reference ID/Investigator# 25894
Bristol, United Kingdom, BS1 2LX
Site Reference ID/Investigator# 73356
Liverpool, United Kingdom, L7 8XP
Site Reference ID/Investigator# 25896
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Andy Payne, PhD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01148225     History of Changes
Other Study ID Numbers: M11-327, 2009-016196-29
Study First Received: May 14, 2010
Last Updated: July 21, 2014
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
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
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AbbVie:
Uveitis
Pan-uveitis
Posterior-Uveitis
Non-infectious Uveitis
Active Uveitis
Intermediate-Uveitis

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Panuveitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014