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Systemic Lupus Erythematosus ArthritisPhase 1/2NCT02429934

Abatacept for SLE Arthritis (IM101-330)

A Phase 1/2 study testing abatacept also known as Orencia also known as CTLA4-Ig in people with Systemic Lupus Erythematosus Arthritis, run by University of California, Los Angeles at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus Arthritis
What is being tested?
abatacept also known as Orencia also known as CTLA4-Ig
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
2 sitesUnited States
Study dates
Oct 2015to 1 Sep 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • ≥3 swollen and tender joints on 2 examinations at least 2 weeks apart and no more than 8 weeks apart.
  • SLEDAI2K score ≥4 indicating active disease.
  • Documented positive ANA (≥1:80) and/or anti-dsDNA during course of SLE.
  • 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.
  • 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.

Who cannot join

  • Subjects with active infection requiring oral or IV antibiotics within one month of first dose of study medication.
  • Subjects with BILAG A in any system outside the musculoskeletal system.
  • Subjects with positive quantiferon Gold test in the absence of treatment for tuberculosis.
  • 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.
  • Subjects with active glomerulonephritis (>3 g protein/24h and/or active urine sediment).
  • Subjects with active CNS disease.
Show all 15Show fewer
  • Subjects with any other serious disease that would require immunosuppressive or parenteral anti-microbial therapy outside the study protocol.
  • Inability to self-administer subcutaneous injections, to comply with instructions, or to keep appointments for study visits.
  • 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.
  • Treatment with any other immunomodulatory biologic or cyclophosphamide during treatment with abatacept is not allowed.
  • Patients requiring >20 mg of prednisone daily.
  • Women who are pregnant or breast feeding.
  • 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.
  • Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection).
  • Any laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UCLA David Geffen School of Medicine, Division of Rheumatology

    Los Angeles, California, 90095

  • University of California, San Diego

    San Diego, California, 92093

Other trials in United States

About this study

Official title: Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)

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.

Read more

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).

Being tested
abatacept also known as Orencia also known as CTLA4-Ig, Placebo
Keywords
Systemic Lupus Erythematosus (SLE), Abatacept (Orencia), Arthritis
Medical subject headings
Lupus Erythematosus, Systemic, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abatacept also known as Orencia also known as CTLA4-IgBiological

    Also called Orencia

    125mg injected subcutaneously weekly for 16 weeks

  • PlaceboDrug

Study groups in NCT02429934
Study groupRoleWhat they receive
Abatacept also known as Orencia also known as CTLA4IgActive comparator32 SLE patients to be treated with subcutaneous abatacept 125mg sq once a week for 16 weeks.
Receives: Biological: abatacept also known as Orencia also known as CTLA4-Ig
PlaceboPlacebo comparator32 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count

    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.

    Measured: Baseline, 8 Weeks, 16 Weeks

Secondary outcomes (9)

  1. Change in SLEDAI 2K

    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.

    Measured: Baseline, 16 weeks

  2. Change in the PGA Score

    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

    Measured: Baseline, 16 weeks

  3. Clinical Disease Activity Index (CDAI) Index Score

    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.

    Measured: 16 weeks

  4. Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS)

    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.

    Measured: Baseline, 16 weeks

  5. Number of AEs and SAEs

    Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug

    Measured: 16 weeks

  6. Number of Tender and Swollen Joints

    Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit

    Measured: baseline, 4, 8, 12 and 16 weeks

  7. Change in the Total Sum of Tender and Swollen Joints

    Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit

    Measured: Baseline, 16 weeks

  8. Number of Patients Who Tapered Prednisone to <10mg/Day

    This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day.

    Measured: 16 weeks

  9. Mean Prednisone Dose (mg/Day)

    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.

    Measured: Baseline, 8 and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion1 Sep 2019
  4. Study completion1 Sep 2019

Why it stopped: Response rate in placebo group for primary outcome was 100% on interim analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02429934
Sponsor's protocol ID
IM101-330 SLE Arthritis
Status last verified
May 2021
First submitted
24 Apr 2015
Last updated
13 May 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing abatacept also known as Orencia also known as CTLA4-Ig in people with Systemic Lupus Erythematosus Arthritis, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02429934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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