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Abatacept for SLE Arthritis (IM101-330)

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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Lupus
Drug Information available for: Abatacept

Arm Intervention/treatment
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
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet at least 4 of the 11 American College of Rheumatology (ACR) 1997 criteria for classification of SLE (see Appendix 1).OR meet the recent classification recommended by SLICC (Appendix 2) 6
  2. ≥3 swollen and tender joints on 2 examinations at least 2 weeks apart and no more than 8 weeks apart.
  3. SLEDAI2K score ≥4 indicating active disease.
  4. Documented positive ANA (≥1:80) and/or anti-dsDNA during course of SLE.
  5. Men and women, at least 18 years of age. Women of childbearing potential must use adequate method(s) of contraception to avoid pregnancy throughout the study and for up to 2 months after last study drug dose. They must have a negative serum or urine pregnancy test prior to the start of study medication.
  6. Background therapies allowed: antimalarials (dose constant for ≥ one month before study entry and during 16 weeks of trial), methotrexate (same criteria as for antimalarials), azathioprine (same criteria), mycophenolate (same criteria), leflunomide (same criteria).

During the screening period and for up to 6 weeks after randomization, a daily prednisone (or equivalent) regimen of up to 20 mg daily may be initiated to treat the moderate to severe disease activity present at screening. The initial steroid regimen is not required if investigators or patients believe that the risks would outweigh the potential benefits. Patients who do not take any glucocorticoids during the study will be included in the treatment groups and analysis.

*Steroids should be tapered to a target dose of no more than 10 mg/day of prednisone (or equivalent) by the end of Week 8 (Day 56). The steroid regimen should be tapered as quickly as safely possible. Prednisone dose requirements higher than 10 mg daily at the 8 week visit will cause the patient to be ruled a non-responder for the abatacept treatment arm.

Exclusion Criteria:

  1. Subjects with active infection requiring oral or IV antibiotics within one month of first dose of study medication.
  2. Subjects with BILAG A in any system outside the musculoskeletal system.
  3. Subjects with positive quantiferon Gold test in the absence of treatment for tuberculosis.
  4. Subjects with positive tests for active infection with hepatitis B or C during the past 6 months. Any confirmed positive test for HIV at any time prior to entry into this study.
  5. Subjects with active glomerulonephritis (>3 g protein/24h and/or active urine sediment).
  6. Subjects with active CNS disease.
  7. Subjects with any other serious disease that would require immunosuppressive or parenteral anti-microbial therapy outside the study protocol.
  8. Inability to self-administer subcutaneous injections, to comply with instructions, or to keep appointments for study visits.
  9. Treatment with rituximab within the past 6 months (B cells must be detectable in peripheral blood at onset of treatment with study biologic), belimumab within the past 5 months, cyclophosphamide within the past 3 months.
  10. Treatment with any other immunomodulatory biologic or cyclophosphamide during treatment with abatacept is not allowed.
  11. Patients requiring >20 mg of prednisone daily.
  12. Women who are pregnant or breast feeding.
  13. Women of child bearing potential unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 2 months after last study drug.
  14. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection).
  15. Any laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of California, Los Angeles
Bristol-Myers Squibb
Investigators
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Principal Investigator: Bevra Hahn, M.D. University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by University of California, Los Angeles:
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02429934    
Other Study ID Numbers: IM101-330 SLE Arthritis
First Posted: April 29, 2015    Key Record Dates
Results First Posted: May 13, 2021
Last Update Posted: May 13, 2021
Last Verified: May 2021
Keywords provided by University of California, Los Angeles:
Systemic Lupus Erythematosus (SLE)
Abatacept (Orencia)
Arthritis
Additional relevant MeSH terms:
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Arthritis
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents