Abatacept for SLE Arthritis (IM101-330)

• Register: ClinicalTrials.gov
• Last refreshed on: 24 May 2021
• Main ID: NCT02429934
• Date of registration: 24/04/2015
• Prospective Registration: Yes
• Primary sponsor: University of California, Los Angeles
• Public title: Abatacept for SLE Arthritis (IM101-330)
• Scientific title: Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: October 2015
• Target sample size: 28
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02429934
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Bevra Hahn, M.D.
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus Arthritis

Intervention(s)

Biological: abatacept also known as Orencia also known as CTLA4-Ig

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

Change in SLEDAI 2K [Time Frame: Baseline, 16 weeks]

Change in the Total Sum of Tender and Swollen Joints [Time Frame: Baseline, 16 weeks]

Clinical Disease Activity Index (CDAI) Index Score [Time Frame: 16 weeks]

Number of Tender and Swollen Joints [Time Frame: baseline, 4, 8, 12 and 16 weeks]

Number of AEs and SAEs [Time Frame: 16 weeks]

Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) [Time Frame: Baseline, 16 weeks]

Number of Patients Who Tapered Prednisone to <10mg/Day [Time Frame: 16 weeks]

Change in the PGA Score [Time Frame: Baseline, 16 weeks]

Mean Prednisone Dose (mg/Day) [Time Frame: Baseline, 8 and 16 weeks]

Secondary ID(s)

IM101-330 SLE Arthritis

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

Results

• Results available: Yes
• Date Posted: 13/05/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02429934