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

  Show 91 Study Locations
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:
Panuveitis
Uveitis
Chorioretinitis
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 September 11, 2014