A Phase 2 interventional study of Tocilizumab and Discontinue Tocilizumab in Giant Cell Arteritis (GCA), sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 7 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
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. High dose TCZ treatment includes 6-8 mg/kg intravenously (IV) monthly or 162 mg subcutaneously (SC) weekly, which are two forms of administration that are commonly used in clinical practice and are equally efficacious in controlling GCA
This research study has three parts:
The primary objective is to determine the rate of disease relapse at 18 months in participants with GCA who receive low-dose TCZ compared to those who discontinue TCZ
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's planned enrollment of 78 is above the median of 64 across 65 interventional studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 artery tenderness or decreased pulsation, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
ii. Symptoms of polymyalgia rheumatica (PMR), defined as shoulder and / or hip girdle pain associated with inflammatory morning stiffness
b. AND at least one of the following:
i. Artery revealing features of GCA (e.g., mononuclear cell infiltration or granulomatous inflammation)
ii. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as ultrasound (US), Magnetic resonance angiography (MRA), computerized tomography angiography (CTA), or Positron emission tomography-computerized tomography (PET-CT)
iii. Ultrasound (US) or Magnetic resonance imaging (MRI) or PET/CT demonstration of features of GCA in a cranial artery
-free remission on Tacrolimus (TCZ) therapy according to the following criteria:
Exclusion Criteria:
Concomitant treatment with another biologic (e.g., etanercept, adalimumab, infliximab, certolizumab, golimumab, sarilumab, abatacept, rituximab, or secukinumab) within 12 months prior to randomization. Concomitant treatment with non-biologic immunosuppressants (e.g.
JAK inhibitors, Methotrexate (MTX)) within 3 months prior to randomization. An exception is hydroxychloroquine, which is permitted as long as the dose has been stable for the 8 weeks preceding randomization
Serologic evidence of chronic hepatitis infection at time of TCZ initiation or at screening if not previously assessed:
Positive interferon gamma release assay (IGRA) (e.g., QuantiFERON Gold or equivalent) at time of TCZ initiation or at screening if not previously assessed
Any of the following laboratory values during screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomization will be performed within strata defined by gender, whether the participant has a history of Giant cell arteritis (GCA) relapse, and whether the participant has a history of polymyalgia rheumatica (PMR) symptoms. Patients in remission of high dose Tocilizumab (TCZ) \>=12months and discontinued glucocorticoids (e.g. prednisone) \>=3 months will receive 162mg subcutaneously (SC) every 2 weeks or 4mg/Kg intravenously (IV) monthly for 18 months Participants who remain in remission will enter the Follow-Up Phase for an additional 12 months at Month 18 and will discontinue TCZ at that time
Drug: Tocilizumab
Randomization will be performed within strata defined by gender, whether the participant has a history of Giant cell arteritis (GCA) relapse, and whether the participant has a history of PMR symptoms. Patients in remission of high dose Tocilizumab (TCZ) \>=12months and discontinued glucocorticoids (e.g. prednisone) \>=3 months will discontinue Tocilizumab and will have visits at Week 2, Month 1 and 2, and then every 2 months during the TCZ Withdrawal Phase until the Month 18 Visit. Participants who remain in remission will enter the Follow-Up Phase for an additional 12 months at Month 18 and will continue withdrawal at that time.
Drug: Discontinue Tocilizumab
Participants will continue Tocilizumab (TCZ) at a lower dose of either 4 mg/kg IV monthly or 162 mg SC every 2 weeks Participants randomized to the stepped-down treatment arm will receive TCZ on their current route of administration. The route of administration may change if needed during study participation at the discretion of the investigator
Also known as: ACTEMRA
Participants will discontinue Tocilizumab and will have visits at Week 2, Month 1 and 2, and then every 2 months during the TCZ Withdrawal Phase until the Month 18 Visit. Participants who remain in remission will enter the Follow-Up Phase for an additional 12 months at Month 18 and will continue withdrawal at that time.
Also known as: ACTEMRA
Proportion of patients in sustained remission
Sustained remission and clinical relapse will be determined by the investigator based on clinical signs and symptoms of active Giant cell arteritis (GCA) and PMR regardless of the values of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). The absence of clinical signs and symptoms of active GCA and PMR over the TCZ Withdrawal/Step-Down Dosing and Follow-Up Phases will define sustained remission through Months 18 and 30, respectively. Clinical relapse will be based on recurrent signs or symptoms attributed to GCA regardless of the values of ESR and CRP. To fulfill the definition of a disease relapse, the investigator must make the decision to intensify the participants GCA treatment
Time frame: Through Month 18
Time to disease relapse
Time frame: Through Month 30
Number of disease relapses
Time frame: At Months 18 and 30
Annualized relapse rate
Time frame: At Months 18 and 30
Cumulative prednisone (or equivalent) dose
Time frame: At Months 18 and 30
Cumulative Glucocorticoid Toxicity Index (GTI) excluding the bone density domain
calculated as the cumulative worsening score (CWS) and aggregate improvement score (AIS)
Time frame: At Months 18 and 30
Clinical features of disease relapse
Sustained remission and clinical relapse will be determined by the investigator based on clinical signs and symptoms of active Giant cell arteritis (GCA) and PMR regardless of the values of ESR and CRP. The absence of clinical signs and symptoms of active GCA and PMR over the TCZ Withdrawal/Step-Down Dosing and Follow-Up Phases will define sustained remission through Months 18 and 30, respectively. Clinical relapse will be based on recurrent signs or symptoms attributed to GCA regardless of the values of ESR and CRP. To fulfill the definition of a disease relapse, the investigator must make the decision to intensify the participants GCA treatment
Time frame: Through Month 30
The number of Adverse Events (AEs)
Time frame: At Months 18 and 30
The nature of Adverse Events (AEs)
Time frame: At Months 18 and 30
The severity of Adverse Events (AEs)
Time frame: At Months 18 and 30
The number of Serious Adverse Events (SAEs)
Time frame: At Months 18 and 30
The nature of Serious Adverse Events (SAEs)
Time frame: At Months 18 and 30
Proportion of patients in sustained remission
Time frame: Through Month 30
Plan to share: Yes — Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Time frame: On average, within 24 months after database lock for the trial.
Access criteria: Open access
Data sharing details ↗ · www.immport.org
Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Tocilizumab
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