Giant Cell ArteritisPhase 2HORTOCINCT01910038
Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
A Phase 2 study testing corticoids+ tocilizumab 8mg/Kg/4 weeks in people with Giant Cell Arteritis, run by Centre Hospitalier Universitaire Dijon at 8 sites in France.
Trial summary
It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- corticoids+ tocilizumab 8mg/Kg/4 weeks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesFrance
- Study dates
- 8 Nov 2013to 13 Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years
- GCA fulfilling ≥3/5 ACR criteria
- Newly diagnosed GCA or relapsing GCA if treatments (Glucocorticoids±immunosuppressants) have been stopped for at least 6 months
- Glucocorticoids started for less than 21 days
- Proof of large vessel vasculitis:
- Positive temporal artery biopsy (TAB)
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- Aortitis, as defined by regular circumferential wall thickening ≥3mm in the absence of calcification and/or significant atheroma on angio-CT images; or a homogeneous vascular signal more intense than the liver on 18FDG-PET images.
- For men and women of a child-bearing age, an effective method of contraception must be used by the patient or his or her partner throughout the treatment with tocilizumab (or placebo) and for 3 months after the end of the treatment. Breast-feeding is not authorised until 3 months after the end of treatment with tocilizumab. Women not considered at risk of pregnancy are those defined by menopause of at least one year or surgically steriles (ligature of the fallopian tubes, bilateral ovariectomy or hysterectomy)
- Persons who have provided written informed consent
- Persons covered by the National Health Insurance Agency
Who cannot join
- Pregnancy
- hospitalization in the previous year for drug or alcohol intoxication
- current treatment for another autoimmune or inflammatory disease
- known hypersensitivity to TCZ or one of its excipients or another human or murine monoclonal antibody
- treatment with anti-TNF-α, methotrexate, cyclophosphamide, dapsone, methylprednisolone pulses or any other immunosuppressive or immunomodulatory drug or biotherapy within 6 months before inclusion
- long-course systemic GC therapy
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- prednisone therapy >1 mg/kg/day, whatever the duration
- serious or chronic proven infections requiring hospitalization or intravenous antibiotics within 30 days before inclusion
- other proven infections that required antibiotics within 14 days before inclusion
- opportunistic infections
- evidence of active tuberculosis or latent tuberculosis (as defined by a positive interferon gamma release assay)
- active chronic hepatitis B or C or HIV
- cancer or lymphoproliferative disorders within the 5 years before inclusion (with the exception of in situ cervical cancer and squamous or basal cell carcinoma with R0 resection)
- past history of sigmoid diverticulitis
- any active hepatic disease
- hepatic failure; thrombocytopenia <50 G/L
- neutropenia <0.5 G/L
- history of moderate to severe congestive heart failure or demyelinating disease
- recent stroke
- current signs or symptoms of severe, progressive, or uncontrolled disease, not due to GCA, which contraindicates TCZ
- severe and uncontrolled hypercholesterolemia
- high cardiovascular risk (former cerebral or coronary vascular event, or vascular risk >20% at 10 years according to the Framingham risk score [24]); dementia; non-compliant patients
- patients under ward of court, tutelage or legal guardianship.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Caen - Hôpital Côte de Nacre
Caen, 14033
CHU de Dijon
Dijon, 21079
Chu Dupuytren
Limoges, 87042
Hôpital Edouard HERRIOT
Lyon, 69437
Hôpitaux privés de Metz - Site Sainte Blandine
Metz, 57045
Institut Mutualiste Montsouris
Paris, 75014
Hôpital La Pitié-Salpêtrière
Paris, 75651
Hôpital COCHIN
Paris, 75679
About this study
It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.
- Conditions
- Giant Cell Arteritis
- Being tested
- corticoids+ tocilizumab 8mg/Kg/4 weeks
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticoids+ tocilizumab 8mg/Kg/4 weeksDrug
| Study group | Role | What they receive |
|---|---|---|
| Prednisone+Tocilizumab | Experimental | Prednisone (0.7 mg/Kg/d and then progressively tapered to reach 0.1 mg/Kg/d at W24) + tocilizumab 8mg/Kg/4 weeks for a total of 4 infusions (S0, S4, S8, S12). Receives: Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day
Remission: absence of symptoms attributable to Giant Cell Arteritis and normalization of inflammatory markers (CRP<10 mg/L and ESR<30 mm/h).
Relapse: recurrence of symptoms attributable to active GCA and/or increased levels of inflammatory markers (CRP≥10 mg/L and/or ESR≥30 mm/h). Elevation of inflammatory markers in the absence of GCA symptoms was considered relapse if it persisted at two time points at 1 week apart without any other obvious etiology than GCA.
Measured: Week 26
Secondary outcomes (5)
Frequency and type of adverse effects encountered
Measured: Until Week 52
Percentage of relapses
Measured: Week 26 and Week 52
Time to the first relapse
Measured: Until Week 52
Factors associated with the occurrence of relapse
Measured: Until Week 52
The cumulative dose of prednisone.
Measured: Weeks 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study start8 Nov 2013
- Primary completionDec 2015
- Study completion13 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910038
- Sponsor's protocol ID
- Bonnotte PHRC N 2012
- Acronym
- HORTOCI
- Status last verified
- Nov 2017
- First submitted
- 17 Jul 2013
- Last updated
- 30 Nov 2017
- Results posted
- No
Publications
Samson M, Devilliers H, Ly KH, Maurier F, Bienvenu B, Terrier B, Charles P, Guillevin L, Besancenot JF, Liozon E, Fauchais AL, Loffroy R, Binquet C, Audia S, Seror R, Mariette X, Bonnotte B. Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study. Eur J Intern Med. 2018 Nov;57:96-104. doi: 10.1016/j.ejim.2018.06.008. Epub 2018 Jul 24.
PubMed 30054122
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
- ClinicalTrials.gov ID
- NCT01910038
- Acronym / sponsor ID
- HORTOCI / Bonnotte PHRC N 2012
- Conditions
- Giant Cell Arteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Nov 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 13 Jun 2016 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisone+Tocilizumab | Experimental | Drug: corticoids+ tocilizumab 8mg/Kg/4 weeksPrednisone (0.7 mg/Kg/d and then progressively tapered to reach 0.1 mg/Kg/d at W24) + tocilizumab 8mg/Kg/4 weeks for a total of 4 infusions (S0, S4, S8, S12). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 50 years
- GCA fulfilling ≥3/5 ACR criteria
- Newly diagnosed GCA or relapsing GCA if treatments (Glucocorticoids±immunosuppressants) have been stopped for at least 6 months
- Glucocorticoids started for less than 21 days
- Proof of large vessel vasculitis:
Key exclusion criteria (23 listed)
- Pregnancy
- hospitalization in the previous year for drug or alcohol intoxication
- current treatment for another autoimmune or inflammatory disease
- known hypersensitivity to TCZ or one of its excipients or another human or murine monoclonal antibody
- treatment with anti-TNF-α, methotrexate, cyclophosphamide, dapsone, methylprednisolone pulses or any other immunosuppressive or immunomodulatory drug or biotherapy within 6 months before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corticoids+ tocilizumab 8mg/Kg/4 weeks | Drug | Prednisone+Tocilizumab |
Primary outcome
Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day
Time frame: Week 26
Remission: absence of symptoms attributable to Giant Cell Arteritis and normalization of inflammatory markers (CRP<10 mg/L and ESR<30 mm/h). Relapse: recurrence of symptoms attributable to active GCA and/or increased levels of inflammatory markers (CRP≥10 mg/L and/or ESR≥30 mm/h). Elevation of inflammatory markers in the absence of GCA symptoms was considered relapse if it persisted at two time points at 1 week apart without any other obvious etiology than GCA.
5 secondary outcomes
Frequency and type of adverse effects encountered
Time frame: Until Week 52
Percentage of relapses
Time frame: Week 26 and Week 52
Time to the first relapse
Time frame: Until Week 52
Factors associated with the occurrence of relapse
Time frame: Until Week 52
The cumulative dose of prednisone.
Time frame: Weeks 26 and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Derived from this study: PubMed 30054122Samson M, Devilliers H, Ly KH, Maurier F, Bienvenu B, Terrier B, Charles P, Guillevin L, Besancenot JF, Liozon E, Fauchais AL, Loffroy R, Binquet C, Audia S, Seror R, Mariette X, Bonnotte B. Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study. Eur J Intern Med. 2018 Nov;57:96-104. doi: 10.1016/j.ejim.2018.06.008. Epub 2018 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing corticoids+ tocilizumab 8mg/Kg/4 weeks in people with Giant Cell Arteritis, run by Centre Hospitalier Universitaire Dijon at 8 sites in France.
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 10 inclusion and 23 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: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day (time frame: Week 26). 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 NCT01910038, which also lists 1 linked publication.
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 30 Nov 2017.