Abatacept for SLE Arthritis (IM101-330)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02429934|
Recruitment Status : Terminated (Response rate in placebo group for primary outcome was 100% on interim analysis.)
First Posted : April 29, 2015
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE.
The purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly for 16 weeks versus placebo injections(a substance with no active ingredients and therefore may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The effectiveness will be assessed primarily by the number of swollen, tender joints (called a joint count) at each of study visits.
Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by prescription and has not been approved by the U.S. Food and Drug Administration for treating SLE yet.
In this study, subjects will receive treatment with either abatacept or placebo once a week for 16 weeks (a total of 16 injections).
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Arthritis||Biological: abatacept also known as Orencia also known as CTLA4-Ig Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||September 1, 2019|
|Actual Study Completion Date :||September 1, 2019|
Active Comparator: Abatacept also known as Orencia also known as CTLA4Ig
32 SLE patients to be treated with subcutaneous abatacept 125mg sq once a week for 16 weeks.
Biological: abatacept also known as Orencia also known as CTLA4-Ig
125mg injected subcutaneously weekly for 16 weeks
Other Name: Orencia
Placebo Comparator: Placebo
32 SLE patients to be treated with subcutaneous placebo once a week for 16 weeks. Injection will be vehicle injected subcutaneously once a week for 16 weeks
- Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count [ Time Frame: Baseline, 8 Weeks, 16 Weeks ]Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit.
- Change in SLEDAI 2K [ Time Frame: Baseline, 16 weeks ]Systemic Lupus Erythematosus Disease Activity Index (Modified in the year 2000) - The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease of 3 points in SLEDAI 2K is considered to be a clinically significant improvement.
- Change in the PGA Score [ Time Frame: Baseline, 16 weeks ]Physician's Global Assessment (PGA) is a physician rating of patient's disease activity, with a range 0-3. A change of 0.8 points on a 3 point scale or less is considered as stable. Lower score means better outcome
- Clinical Disease Activity Index (CDAI) Index Score [ Time Frame: 16 weeks ]CDAI is a simplified index for assessing disease activity comprising swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity.
- Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) [ Time Frame: Baseline, 16 weeks ]Using ultrasound analysis, (Gray scale ultrasound) represents synovitis/tenosynovitis and identifies erosions. PDUS (power Doppler ultrasound) measures intensity of soft tissue inflammation by blood flow. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint. A higher value of the total score for GSUS represents more severe disease level.
- Number of AEs and SAEs [ Time Frame: 16 weeks ]Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug
- Number of Tender and Swollen Joints [ Time Frame: baseline, 4, 8, 12 and 16 weeks ]Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit
- Change in the Total Sum of Tender and Swollen Joints [ Time Frame: Baseline, 16 weeks ]Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit
- Number of Patients Who Tapered Prednisone to <10mg/Day [ Time Frame: 16 weeks ]This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day.
- Mean Prednisone Dose (mg/Day) [ Time Frame: Baseline, 8 and 16 weeks ]prednisone dose (mg/day) is recorded at baseline, 8 and 16 weeks for each subject being assessed at that study visit. Then a mean for all the subjects in each group at each time point was calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429934
|United States, California|
|UCLA David Geffen School of Medicine, Division of Rheumatology|
|Los Angeles, California, United States, 90095|
|University of California, San Diego|
|San Diego, California, United States, 92093|
|Principal Investigator:||Bevra Hahn, M.D.||University of California, Los Angeles|