Overview

This trial is active, not recruiting.

Condition uveitis
Treatment adalimumab
Phase phase 3
Target TNF-alpha
Sponsor AbbVie (prior sponsor, Abbott)
Start date November 2010
End date March 2018
Trial size 400 participants
Trial identifier NCT01148225, 2009-016196-29, M11-327

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
adalimumab ABT-D2E7
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.

Primary Outcomes

Measure
Evaluation of Adverse Events
time frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks)
Significant laboratory value changes
time frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks)
Significant vital sign changes
time frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks)

Secondary Outcomes

Measure
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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 330 weeks)
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)
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 330 weeks)

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.