Trial Outcomes & Findings for Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population (NCT NCT01782469)

NCT ID: NCT01782469

Last Updated: 2015-07-30

Results Overview

Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.

• Recruitment status: TERMINATED
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline (Visit 1) to 13 weeks
• Results posted on: 2015-07-30

Participant Flow

Participant milestones

Measure	Rheumatoid Arthritis (RA) Participants Male or female participants at least 18 years of age with diagnosis of RA
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Rheumatoid Arthritis (RA) Participants Male or female participants at least 18 years of age with diagnosis of RA
Overall Study Lost to Follow-up	1

Baseline Characteristics

Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

Baseline characteristics by cohort

Measure	Rheumatoid Arthritis (RA) Participants n=16 Participants Male or female participants at least 18 years of age with diagnosis of RA
Age, Continuous	36.5 years STANDARD_DEVIATION 9.27 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 1) to 13 weeks

Population: Participants with available data

Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.

Outcome measures

Measure	Rheumatoid Arthritis (RA) Participants n=15 Participants Male or female participants at least 18 years of age with diagnosis of RA
Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.	-9.6 units on a scale Standard Deviation 4.98

SECONDARY outcome

Timeframe: Baseline (Visit 1) to 13 weeks

Population: Participants with available data

Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.

Outcome measures

Measure	Rheumatoid Arthritis (RA) Participants n=16 Participants Male or female participants at least 18 years of age with diagnosis of RA
Mean Percent Reduction in Ultrasonography Assessment Score Visit 2, n=16	-20.99 Percent reduction Standard Deviation 18.4
Mean Percent Reduction in Ultrasonography Assessment Score Visit 3, n=16	-35.60 Percent reduction Standard Deviation 25.36
Mean Percent Reduction in Ultrasonography Assessment Score Visit 4, n=16	-48.42 Percent reduction Standard Deviation 19.88
Mean Percent Reduction in Ultrasonography Assessment Score Visit 5, n=15	-56.91 Percent reduction Standard Deviation 24.81

SECONDARY outcome

Timeframe: Baseline (Visit 1) to 13 weeks

Population: Participants with available data

A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.

Outcome measures

Measure	Rheumatoid Arthritis (RA) Participants n=16 Participants Male or female participants at least 18 years of age with diagnosis of RA
Mean Number of Joints With Detected Erosions Visit 1, n=16	9.38 joints Standard Deviation 1.89
Mean Number of Joints With Detected Erosions Visit 2, n=16	8.69 joints Standard Deviation 2.5
Mean Number of Joints With Detected Erosions Visit 3, n=16	7.69 joints Standard Deviation 3.3
Mean Number of Joints With Detected Erosions Visit 4, n=16	6.75 joints Standard Deviation 3.24
Mean Number of Joints With Detected Erosions Visit 5, n=15	6.07 joints Standard Deviation 2.91

SECONDARY outcome

Timeframe: Baseline (Visit 1) to 13 weeks

Population: All enrolled participants

The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).

Outcome measures

Measure	Rheumatoid Arthritis (RA) Participants n=16 Participants Male or female participants at least 18 years of age with diagnosis of RA
Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)	93.75 percentage of participants Interval 80.4 to 107.1

SECONDARY outcome

Timeframe: Baseline (Visit 1) to 13 weeks

Population: Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.

Outcome measures

Measure	Rheumatoid Arthritis (RA) Participants n=16 Participants Male or female participants at least 18 years of age with diagnosis of RA
Mean Change in Health Assessment Questionnaire (HAQ) Score	1.19 units on a scale Standard Deviation 0.65

Adverse Events

Rheumatoid Arthritis (RA) Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER