Trial · NCT01148225

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

NCT01148225, Phase 3, Completed, AbbVie; results first posted 2019-04-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis. Trials, record NCT01148225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01148225

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
NCT number: NCT01148225
Status: Completed
Phases: Phase 3
Enrollment: 424 participants, actual
Lead sponsor: AbbVie
Conditions: Uveitis
Interventions: adalimumab
First posted: 2010-06-22
Last updated: 2021-07-12
Other registries' IDs: eudract:2009-016196-29
Results first posted: 2019-04-04

Source ClinicalTrials.gov

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	Baseline to Final Visit (up to 366 weeks)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.
Primary	Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values	Baseline to Final Visit (Up to 366 weeks)	PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations used include g=grams; L=liters.
Primary	Chemistry: Number of Participants With PCS Values	Baseline to Final Visit (Up to 366 weeks)	PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase; AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase; g/L=grams/liter; mmol/L=millimoles/liter; ULN=upper limit of normal.
Primary	Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Heart rate (beats per minute) was measured while the participant was sitting.
Primary	Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Respiratory rate (respirations per minute) was measured while the participant was sitting.
Primary	Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Temperature was measured while the participant was sitting.
Primary	Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
Secondary	Percentage of Participants in Quiescence Over Time	Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246	Quiescence is defined as no active inflammatory lesions and anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤0.5+. Participants with active uveitis at study entry could have been in quiescence at Week 0 because all participants were evaluated for uveitis status at the Final/Early Termination visit of the lead-in study and the Week 0 visit could have occurred up to 28 days later during which time the participant's disease status may have changed.
Secondary	Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start	366 Weeks	Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).
Secondary	Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start	Weeks 8 to 246 (238 Weeks)	Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).

1 to 10 of 35Source ClinicalTrials.gov

See all 35 registered outcomes

Outcomes35

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	Baseline to Final Visit (up to 366 weeks)	Safety analysis set: includes all participants who received at least one dose of study medication.	participants	NUMBER
PRIMARY	Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values	Baseline to Final Visit (Up to 366 weeks)	Safety analysis set.	participants	NUMBER
PRIMARY	Chemistry: Number of Participants With PCS Values	Baseline to Final Visit (Up to 366 weeks)	Safety analysis set.	participants	NUMBER
PRIMARY	Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Safety analysis set.	beats per minute	MEAN
PRIMARY	Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Safety analysis set.	respirations per minute	MEAN
PRIMARY	Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Safety analysis set.	Centigrade	MEAN
PRIMARY	Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit	Baseline to Final Visit (Up to 366 weeks)	Safety analysis set.	mmHg	MEAN
SECONDARY	Percentage of Participants in Quiescence Over Time	Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246	ITT analysis set: includes all participants who received at least one dose of study medication with evaluable data at a given timepoint.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start	366 Weeks	All participants in the ITT analysis set with inactive uveitis with evaluable data at a given timepoint.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start	Weeks 8 to 246 (238 Weeks)	All participants in the ITT analysis set with active uveitis at study start with evaluable data at a given timepoint.	percentage of participants	NUMBER

1 to 10 of 35Source ClinicalTrials.gov

See all 35 outcomes

Results by group572

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events	Adalimumab	Any TEAE	398	participants
Number of Participants With Adverse Events	Adalimumab	Any TESAE	101	participants
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values	Adalimumab	Hemoglobin (Low: <80-65 g/L)	3	participants
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values	Adalimumab	Neutrophils (Low: <1.0-0.5*10^9/L)	6	participants
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values	Adalimumab	Lymphocytes (Low: <0.5-0.2*10^9/L)	7	participants
Chemistry: Number of Participants With PCS Values	Adalimumab	ALT/SGPT (High: >5.0-20.0*ULN)	2	participants
Chemistry: Number of Participants With PCS Values	Adalimumab	AST/SGOT (High: >5.0-20.0*ULN)	3	participants
Chemistry: Number of Participants With PCS Values	Adalimumab	Bilirubin, Total (High: >3.0-10.0*ULN)	1	participants
Chemistry: Number of Participants With PCS Values	Adalimumab	Creatinine (High: >3.0-6.0*ULN)	2	participants
Chemistry: Number of Participants With PCS Values	Adalimumab	Phosphate Inorganic (Low:<0.6-0.3 mmol/L)	5	participants

1 to 10 of 572Source ClinicalTrials.gov

See all 572 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Adalimumab	424
Overall Study	COMPLETED	Adalimumab	239
Overall Study	NOT COMPLETED	Adalimumab	185

Source ClinicalTrials.gov

Adverse events158

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	CATARACT	Eye disorders	Adalimumab	30	424	38
other	CYSTOID MACULAR OEDEMA	Eye disorders	Adalimumab	43	424	70
other	DRY EYE	Eye disorders	Adalimumab	30	424	33
other	EYE PAIN	Eye disorders	Adalimumab	25	424	27
other	IRIDOCYCLITIS	Eye disorders	Adalimumab	22	424	29
other	MACULAR OEDEMA	Eye disorders	Adalimumab	24	424	31
other	UVEITIS	Eye disorders	Adalimumab	123	424	217
other	VISUAL ACUITY REDUCED	Eye disorders	Adalimumab	30	424	36
other	DIARRHOEA	Gastrointestinal disorders	Adalimumab	28	424	33
other	NAUSEA	Gastrointestinal disorders	Adalimumab	32	424	45

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Adalimumab	4	424
Total, other adverse events	Adalimumab	332	424
Total, serious adverse events	Adalimumab	101	424

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33157077	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01148225

GET https://conductscience.org/api/trials/v1/NCT01148225/registered?page=2

API reference For AI assistants