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Abatacept for SLE Arthritis (IM101-330)

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ClinicalTrials.gov Identifier: NCT02429934
Recruitment Status : Unknown
Verified May 2016 by Dr. Bevra Hahn, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : April 29, 2015
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dr. Bevra Hahn, 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 Drug: abatacept Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

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
32 SLE patients to be treated with subcutaneous abatacept 125mg sq once a week for 16 weeks.
Drug: abatacept
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.
Drug: Placebo



Primary Outcome Measures :
  1. Baseline to 16 week comparison of at least a 20% improvement in Tender and Swollen 28 joint count over the 16 weeks period [ Time Frame: Week 16 ]
    Comparing dichotomous results for tender and swollen joints for those who improved and those who did not improve by at least 20%


Secondary Outcome Measures :
  1. Baseline to 16 week comparison of SLEDAI 2K improvement between patients in two study arms [ Time Frame: 16 weeks ]
    Change of 3 points in SLEDAI 2K is considered an improvement

  2. Baseline to 16 week comparison of change in the PGA score between patients in two study arms [ Time Frame: 16 weeks ]
    A change of 0.8 points on a 3 point scale or less is considered as stable

  3. Longitudinal changes in CDAI between patients in two study arms [ Time Frame: measured at baseline, 8, 12 and 16 weeks ]
    Comparing means and medians over the length of the study

  4. Baseline to 16 week comparison of changes in the synovitis, tenosynovitis and erosions scores measured by ultrasound between patients in two study arms [ Time Frame: 16 weeks ]
  5. Baseline to 16 week comparison of changes in the FACIT fatigue score between patients in two study arms [ Time Frame: 16 weeks ]
  6. Baseline to 16 week comparison of changes in the SF 36 quality of life score between patients in two study arms [ Time Frame: 16 weeks ]
  7. Difference in the number of AEs and SAEs between patients in two study arms [ Time Frame: 16 weeks ]
    Will compare total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug

  8. Longitudinal changes in the total number of tender and swollen joints between patients in two study arms [ Time Frame: baseline, 4, 8, 12 and 16 weeks ]
  9. Baseline to 16 week change in peripheral blood T cell compartments between patients in two study arms [ Time Frame: 16 weeks ]
  10. Longitudinal change in anti-DNA and total IgG levels as well as Serum complement levels between patients in two study arms [ Time Frame: Baseline 8 and 16 weeks ]
  11. Longitudinal change in serum levels of BAFF between patients in two study arms [ Time Frame: Baseline, 8 and 16 weeks ]
  12. Time to response of 20% improvement in joint counts between patients in two study arms [ Time Frame: baseline, 4, 8, 12 and 16 weeks ]
  13. Comparing baseline to 16 week improvement for the total sum score of tender and swollen joints between the two study arms [ Time Frame: 16 weeks ]
    Changes in Means and Medians will be used as the point of comparison

  14. Comparing the proportion of patients who are able to taper prednisone to <10mg/day by week 16 between the two study arms [ Time Frame: 16 weeks ]
    This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day



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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


Contacts
Contact: Bevra Hahn, M.D. 310-825-7991 bhahn@mednet.ucla.edu
Contact: Bal-lan Yen (310) 206-4112 byen@mednet.ucla.edu

Locations
United States, California
UCLA David Geffen School of Medicine, Division of Rheumatology Recruiting
Los Angeles, California, United States, 90095
Contact: Hahn Bevra, M.D.    310-825-7991    bhahn@mednet.ucla.edu   
Sub-Investigator: Jennifer Grossman, M.D.         
Sub-Investigator: Maureen McMahon, M.D.         
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Kenneth Kalunian, M.D.    858-657-7049    kkalunian@ucsd.edu   
Sponsors and Collaborators
University of California, Los Angeles
Bristol-Myers Squibb
Investigators
Principal Investigator: Bevra Hahn, M.D. University of California, Los Angeles

Responsible Party: Dr. Bevra Hahn, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02429934     History of Changes
Other Study ID Numbers: IM101-330 SLE Arthritis
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Dr. Bevra Hahn, University of California, Los Angeles:
Systemic Lupus Erythematosus (SLE)
Abatacept (Orencia)
Arthritis

Additional relevant MeSH terms:
Arthritis
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents