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Compares treatment options for Giant Cell Arteritis (GCA)
Official title Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
ClinicalTrials.gov ID: NCT07108387
What this study is testing
What is Tocilizumab?
Tocilizumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for giant cell arteritis (gca).
Also referred to as ACTEMRA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance versus withdrawal in Giant cell arteritis (GCA) patients who are in remission after at least 12 months of high dose TCZ treatment. Eligible participants will also have discontinued glucocorticoids (e.g., prednisone (or equivalent)) entirely at least three months before randomization.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Diagnosis of Giant cell arteritis (GCA) classified according to the following criteria: a. AND at least one of the following: i. Cranial signs or...
- Glucocorticoid-free remission on Tacrolimus (TCZ) therapy according to the following criteria:
- Ongoing treatment with TCZ (ACTEMRA(R) or one of its FDA-approved biosimilars) administered at 6-8 mg/kg IV every 4 weeks OR 162 mg subcutaneous (SC)...
- Disease remission for at least 12 months prior to randomization defined as the absence of clinical signs or symptoms of active GCA and Polymyalgia...
You likely can't join if
- An autoimmune disease or other condition, other than Giant cell arteritis (GCA), that requires/is anticipated to require chronic or recurrent oral or...
- Hospitalization within 8 weeks prior to randomization
- Suspected or established adrenal insufficiency
- Treatment with any investigational agent within 12 months of randomization
- Concomitant treatment with another biologic immunosuppressant (e.g., etanercept, adalimumab, infliximab, certolizumab, golimumab, sarilumab...
- Immunization with a live/attenuated vaccine within \<= 4 weeks prior to randomization
See the full eligibility criteria
Who can join
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Diagnosis of Giant cell arteritis (GCA) classified according to the following criteria: a. AND at least one of the following: i. Cranial signs or symptoms of GCA (new-onset localized headache, scalp tenderness, temporal...
- Glucocorticoid-free remission on Tacrolimus (TCZ) therapy according to the following criteria:
- Ongoing treatment with TCZ (ACTEMRA(R) or one of its FDA-approved biosimilars) administered at 6-8 mg/kg IV every 4 weeks OR 162 mg subcutaneous (SC) weekly for at least 12 months prior to randomization. Participants...
- Disease remission for at least 12 months prior to randomization defined as the absence of clinical signs or symptoms of active GCA and Polymyalgia rheumatica (PMR) along with normal values of C-reactive protein (CRP)...
- Absence of oral, IV, intramuscular (IM), or SC glucocorticoid treatment for at least 3 months prior to randomization
What rules you out
- An autoimmune disease or other condition, other than Giant cell arteritis (GCA), that requires/is anticipated to require chronic or recurrent oral or parenteral glucocorticoids or other immunomodulatory therapy...
- Hospitalization within 8 weeks prior to randomization
- Suspected or established adrenal insufficiency
- Treatment with any investigational agent within 12 months of randomization
- Concomitant treatment with another biologic immunosuppressant (e.g., etanercept, adalimumab, infliximab, certolizumab, golimumab, sarilumab, abatacept, rituximab, or secukinumab) within 12 months prior to randomization...
- Immunization with a live/attenuated vaccine within \<= 4 weeks prior to randomization
- History of severe allergic or anaphylactic reactions to Tocilizumab (TCZ) or to prednisone (or equivalent)
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric...
- Serologic evidence of chronic hepatitis infection at time of TCZ initiation or at screening if not previously assessed:
- Evidence of current or prior infection with hepatitis B, as indicated by a positive test for the hepatitis B surface antigen or an isolated positive test for the hepatitis B core antibody. If a participant has an...
- Evidence of current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response \>= 12 weeks. If a participant has a positive or indeterminate hepatitis C antibody...
- Positive interferon gamma release assay (IGRA) (e.g., QuantiFERON Gold or equivalent) at time of TCZ initiation or at screening if not previously assessed
- If the participant has had the BCG vaccine or has some other condition complicating the interpretation of tuberculosis (TB) testing, clearance after consultation with infectious disease specialist or pulmonologist must...
- Participants diagnosed with latent TB are eligible but must have initiated appropriate prophylaxis for at least 30 days prior to initiation of study treatment
- Indeterminate IGRA must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the IGRA remains indeterminate, a participant must have a negative tuberculin purified protein...
- Known active bacterial, viral, fungal, mycobacterial, or other infections except fungal infections of the nail beds and superficial cutaneous infection treated topically
- Participant is pregnant or breastfeeding or planning a pregnancy while enrolled in the study
- Any infection requiring treatment with IV antibiotics within 4 weeks of randomization or oral antibiotics within 2 weeks of randomization
- Active treatment for malignancy at the time of randomization, with exception of prophylactic hormonal therapy (e.g. prostate cancer, breast cancer, etc.)
- History of alcohol, drug, or chemical abuse within 12 months prior to randomization
- History of chronic or recurrent infection (excluding simple cystitis, viral respiratory infection, sinusitis, dermatophyte (tinea) infection) within 12 months prior to randomization
- History of opportunistic infection within 12 months prior to randomization unless evaluated and cleared by an infectious disease or pulmonary specialist
- Any of the following laboratory values during screening:
- Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \> 1.5 × upper limit of normal (ULN)
- Platelet count \< 100 × 10\^9/L (100,000/mm\^3)
- Hemoglobin (Hb) \< 90 g/L (9 g/dL; 5.6 mmol/L)
- White blood cells \< 3.0 × 10\^9/L (3000/mm\^3)
- Absolute neutrophil count (ANC) \< 1.0 × 10\^9/L (1000/mm\^3)
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Great Neck, New York, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Great Neck, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.