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Clinical trial comparing the efficacy and safety of certolizumab pegol and belimumab in patients with moderate or severe activity of systemic lupus erythematosus (CERT-SLE)
EU CTIS ID: 2024-517753-27-01
What this study is testing
The purpose of the study is to compare the efficacy and safety of treatment with certolizumab pegol with the reference therapy belimumab in patients with moderately active or active systemic lupus erythematosus (SLE).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent form
- Patients of childbearing potential should agree to abstinence or use a highly effective method of contraception during the entire study period and for at least 5 months after the last dose of certolizumab pegol or at least 4 months after the last dose of belimumab
- Age 18-65 years
- Ability to follow the study protocol
- Documented diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria at any time before or during screening
- Positive antinuclear antibody (ANA) immunofluorescence test result with a titer of at least 1:80 AND Presence of at least one of the following serological markers of SLE at screening: ● Antibodies against double-stranded DNA (anti-dsDNA); OR ● Anti-Smith antibodies (anti-Sm)
You likely can't join if
- Pregnancy or breastfeeding
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >2 x ULN, if normalization occurs the patient may be considered for a repeat screening visit
- Bilirubin >1.5 x GGN
- History of severe bronchial asthma or other clinically significant pulmonary abnormalities
- NYHA III/IV cardiovascular disease
- Previous stroke, heart attack within 6 months prior to screening
See the full eligibility criteria
Who can join
- Signed informed consent form
- Patients of childbearing potential should agree to abstinence or use a highly effective method of contraception during the entire study period and for at least 5 months after the last dose of certolizumab pegol or at least 4 months after the last dose of belimumab
- Age 18-65 years
- Ability to follow the study protocol
- Documented diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria at any time before or during screening
- Positive antinuclear antibody (ANA) immunofluorescence test result with a titer of at least 1:80 AND Presence of at least one of the following serological markers of SLE at screening: ● Antibodies against double-stranded DNA (anti-dsDNA); OR ● Anti-Smith antibodies (anti-Sm)
- At least moderate SLE activity, defined as meeting all of the following criteria: ● SELENA-SLEDAI score ≥4 indicating active disease ● Physician Global Assessment (PGA) ≥1.0 (on a scale of 0-3)
- Acceptable medications and doses: ● Azathioprine: 1 to 2.5 mg/kg/day ● Methotrexate: 7.5 to 25 mg/week ● Mycophenolate mofetil: 500 to 3000 mg/day ● Hydroxychloroquine: 200 to 400 mg/day ● Chloroquine: 250 to 500 mg/day ● Leflunomide - 10-20 mg/day Patients treated with conventional medications should be on stable doses for ≥ 8 weeks prior to screening visit
- Patients may receive standard treatment but no new therapy has been initiated or therapy has been withdrawn in the 8 weeks prior to the screening visit
- If oral glucocorticosteroids (GCS) are used, the dose must be ≤20 mg/day prednisone (or equivalent) and must be stable for at least 2 weeks prior to study
What rules you out
- Pregnancy or breastfeeding
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >2 x ULN, if normalization occurs the patient may be considered for a repeat screening visit
- Bilirubin >1.5 x GGN
- History of severe bronchial asthma or other clinically significant pulmonary abnormalities
- NYHA III/IV cardiovascular disease
- Previous stroke, heart attack within 6 months prior to screening
- Patients with chronic liver disease (Child Pugh A, B, C liver dysfunction)
- Active or significant history of infection, including treatment with intravenous antibiotics in the last 4 weeks or oral antibiotics in the 2 weeks prior to screening
- A positive SARS-CoV-2 test result during visit “0” is an exclusion criterion, while an infection more than 4 weeks before screening and confirmed by a negative SARS-CoV-2 test is not an exclusion criterion
- Active confirmed tuberculosis or latent without chemoprophylaxis performed in accordance with applicable local recommendations
- Active HBV, HCV infection (acceptable history of HCV after treatment and virus elimination confirmed by PCR test)
- Patients who have ever received any of the study drugs in the past
- Human immunodeficiency virus (HIV) infection
- Diagnosed primary or secondary immunodeficiency
- Active or past malignancy within 5 years prior to screening, except resected/cured localized basal cell or squamous cell carcinoma of the skin or cervical cancer in situ
- Hypogammaglobulinemia (IgG <400 mg/dl) or IgA (IgA <10 mg/dl) deficiency
- Active or past drug or alcohol abuse
- History of severe depression
- The inability to understand and comply with the protocol requirements (lack of compliance) also excludes from participation in the study.
- Patients who received any of the following medications and/or procedures during the indicated time period: ● Plasmapheresis or intravenous immunoglobulin within the last 12 weeks prior to screening ● Lymphatic depleting therapy. B (e.g., anti-CD20 or anti-CD19) within 24 weeks prior to screening ● blisibimod, tabalumab (or other anti-B cell activating factor [BAFF] agents), atacicept, epratuzumab (or other anti-CD22 agents) within 5 half-lives or 12 weeks (whichever is longer) prior to screening ● cyclophosphamide or other alkylating agents within 12 weeks prior to screening ● oral cyclosporine, anakinra, tacrolimus, sirolimus, or other calcineurin inhibitors, topical calcineurin inhibitors within 4 weeks prior to screening ● thalidomide or thalidomide derivatives within 24 weeks prior to screening ● tumor necrosis factor (TNF) antagonists, tocilizumab or other biologics not listed previously used in the past. ● Any other immunosuppressive drug used for SLE not listed in the inclusion criteria within 12 weeks or 5 half-lives prior to screening, whichever is longer
- Patients with active lupus nephritis: ● Proteinuria > 2 g/24 h or equivalent based on albumin/creatinine ratio (ACR) ● Active proliferative lupus nephritis (class III or IV TZN) based on renal biopsy performed within 6 months prior to screening (or during the study). ● Hemodialysis or high-dose corticosteroids (>100 mg/d prednisone or equivalent) for lupus erythematosus renal disease within 90 days of screening ● Serum creatinine > 2.0 mg/dL or estimated glomerular filtration rate ≤ 30 mL/min or chronic renal replacement therapy
- Severe active central nervous system lupus erythematosus within 52 weeks of screening
- Major surgery within 8 weeks prior to screening
- Rheumatic disease other than systemic lupus erythematosus (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis) acceptable diagnosis of secondary Sjögren's syndrome
- Immunization with a live or attenuated vaccine within 4 weeks prior to planned treatment
- Known hypersensitivity to human, humanized or mouse monoclonal antibodies
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.