A study to evaluate the long-term safety of adalimumab in subjects with non-infectious intermediate-, posterior-, or pan-uveitis who participated in Study M10-877 or Study M10-880.

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 - N/A

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016196-29-GB

Enrollment

400

Registered

2010-06-17

Start date

2010-09-21

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious Intermediate-, Posterior-, or Pan-uveitis MedDRA version: 20.0 Level: LLT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 100000161411 MedDRA version: 20.0 Level: LLT Classification code 10033687 Term: Panuveitis System Organ Class: 100000014975 MedDRA version: 20.0

Interventions

Trade Name: Humira 40 mg solution for injection in pre-filled syringes Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Subject must have successfully enrolled in either Study M10-877 or Study M10-880 and either met the endpoint of "Treatment Failure" or completed the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: • A subject will be excluded from this study if the patient prematurely discontinued from Study M10-877 or Study M10-880 for any reason 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.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: Please see E.5.1.;Main Objective: The primary objective of this study is to evaluate the long-term safety of adalimumab 40 mg given every other week (eow) subcutaneously (SC) in subjects with non-infectious intermediate-, posterior-, or pan-uveitis who participated in Study M10-877 or Study M10-880. Long-term efficacy will also be assessed.; Primary end point(s): ? 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 and to Week 8 for subjects who had active uveitis when they entered the study. ? Proportion of subjects at each study time point with a Grade or = 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study. ? 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 and to Week 8 for subjects who had active uveitis when they entered the study. ? 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 and to Week 8 for subjects who had active uveitis when they entered the study. ? Proportion of subjects at each study time point achieving a > or = 50% reduction in immunosuppression load relative to Baseline for subjects who	—

Measure

Time frame

Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: Please see E.5.1.;Main Objective: The primary objective of this study is to evaluate the long-term safety of adalimumab 40 mg given every other week (eow) subcutaneously (SC) in subjects with non-infectious intermediate-, posterior-, or pan-uveitis who participated in Study M10-877 or Study M10-880. Long-term efficacy will also be assessed.; Primary end point(s): ? 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 and to Week 8 for subjects who had active uveitis when they entered the study. ? Proportion of subjects at each study time point with a Grade or = 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study. ? 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 and to Week 8 for subjects who had active uveitis when they entered the study. ? 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 and to Week 8 for subjects who had active uveitis when they entered the study. ? Proportion of subjects at each study time point achieving a > or = 50% reduction in immunosuppression load relative to Baseline for subjects who

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trials Helpdesk

AbbVie Ltd.

eu-clinical-trials@abbvie.com+44 1628 773355

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026