VasculitisPhase 2TRIBECANCT04629144
Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)
A Phase 2 study testing Belimumab in people with Vasculitis and Cryoglobulinemia, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
Trial summary
Cryoglobulinemia vasculitis (CV) is a systemic immune-mediated small vessel vasculitis. Rituximab proved effective on main vasculitis signs, with a complete clinical response of 65%. However, CV relapse is noted in up to 40% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculitis, Cryoglobulinemia
- What is being tested?
- Belimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 20 sitesFrance
- Study dates
- 20 Oct 2021to 20 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The eligibility criteria will be checked at the inclusion/randomization visit. Patients meeting the following criteria may be included in the study:
- Age > 18 years
- Written inform consent
- Active mixed cryoglobulinemia vasculitis, at initiation of rituximab, define by a. a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement , b. history of positive cryoglobulinemia and/or positive Rheumatoid factor associated with low C4 complement level , and/or a monoclonal component (IgM Kappa) and/or a histologal proof of vasculitis in the affected organs
- Affiliated to National French social security system
- Having received Rituximab as induction therapy within 6 weeks (1 to 4 infusions, dose at the discretion of the investigator)
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- Female subjects of childbearing potential must have a negative serum or urinary pregnancy test at inclusion visit, and confirmed monthly while in study, out to at least 92 days (5 half lives) post last dose.
- For subjects with reproductive potential (male or female), a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study from 2 weeks prior to administration of the 1st dose of study agent until 92 days after the last dose of study agent. Therefore the subjects agree to 1 of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 92 days after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) OR
- Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 92 days after the last dose of study agent o Oral contraceptive, either combined or progestogen alone o Injectable progestogen o Implants of levonorgestrel or etonogestrel o Estrogenic vaginal ring o Percutaneous contraceptive patches o Intrauterine device (IUD) or intrauterine system (IUS) with <1% failure rate as stated in the product label
- o Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records
- Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.
- HIV negative serology ; negative HBs Ag test and HBc Ab test; HCV negative serology or negative HCV RNA if positive HCV serology within 3 months before inclusion:
- o In case of negative AgHBs and positive HBc Ab test, HBV DNA test must be negative; AND Hepatitis B surveillance should be started (monthly HBsAg and HBV DNA testing for the duration of the study treatment and at least every 12 weeks after treatment is discontinued for the duration of study treatment. In addition, antiviral prophylaxis should be started before the first administration of the study treatment and continued until 12 months after completion of study treatment; HCV negative serology or negative HCV RNA if positive HCV serology within 3 months before inclusion
- neutrophils (ANC) >1x109/L
Who cannot join
- Subjects will be not included from the study if they meet any of the following criteria:
- Patient with a vasculitis unrelated to cryoglobulinemia
- Patient with non active cryoglobulinemia vasculitis, at initiation of rituximab. Patients with mixed inactive vasculitis following rituximab administration may be included.
- Excluded concomitant medications:
- 365 days Prior to Investigational Medicinal Product (Belimumab or placebo):: Any biologic investigational agent (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131) Investigational agent applies to any drug not approved for sale in the country in which it is being used
- 180 Days Prior to Investigational Medicinal Product (Belimumab or placebo):: Intravenous cyclophosphamide
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- 30 Days Prior to Investigational Medicinal Product (Belimumab or placebo): (or 5 half lives, whichever is greater) Any non-biologic investigational agent Investigational agent applies to any drug not approved for sale in the country in which it is being use
- Live vaccines within 30 days prior to baseline or concurrently with Investigational Medicinal Product (Belimumab or placebo)
- Have a history of malignant neoplasm within the last 5 years, other than carcinoma in situ of the cervix or excised basal cell, squamous cell carcinoma of the skin and low grade hemopathy with no indication for a specific treatment
- Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
- Have a Progressive multifocal leukoencephalopathy
- Have a history of a primary immunodeficiency
- 9. Have a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant
- 10. Infection history:
- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus
- Infection requiring hospitalization and/or use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of the inclusion visit.
- 11. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to the inclusion visit
- 12. Have a historically positive HIV test according to results obtained within 3 months prior to inclusion visit
- 13. Hepatitis status according to results obtained within 3 month prior to inclusion visit :
- Positive test for hepatitis B RNA
- Positive test for Hepatitis C RNA
- 14. Have a history of a hypersensitivity or an anaphylactic reaction to parenteral administration of Belimumab, corticosteroids or any excipients of the treatments administered during the study
- 15. If Women of Child Bearing Potential (WCBP) are included please see special instructions in Inclusion criteria
- 16. Pregnant or breast feeding women
- 17. Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study
- 18. Patients under legal protection or unable to consent
- 19. Participation to another interventional study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
CH Blois
Blois
Bertrand Lioger, MD
- Recruiting
CHU (Haut-Lévêque)
Bordeaux
Estibaliz Lazaro, MD
- Recruiting
CHU Caen
Caen
Achille Aouba, MD
- Not yet recruiting
Hopital Henri Mondor
Créteil
Marc Michel, MD
- Recruiting
Hopital Bicetre
Le Kremlin-Bicêtre
Xavier Mariette, MD
- Recruiting
CHU Lille
Lille
Eric Hachulla, MD
- Recruiting
CHU La Conception
Marseille
Gilles Kaplanski, MD
- Recruiting
CHU Nantes
Nantes
Antoine Neel, MD
- Recruiting
CH Nimes
Nîmes
Olivier Moranne, MD
- Recruiting
Hopital de La Pitié Salpetriere AP-HP
Paris
David Saadoun, MD PhD
- Recruiting
Hopital Européen Georges Pompidou
Paris
Alexandre Karras, MD
- Recruiting
Hopital Necker
Paris
Aurélie Hummel, MD
- Recruiting
Hopital Saint Antoine
Paris
Arsene Mekinian, MD
- Recruiting
Hopital Saint Louis
Paris
Baptiste Hervier, MD
- Recruiting
Hopital Tenon
Paris
Jean-Jacques Boffa, MD
- Recruiting
CHU Starsbourg
Strasbourg
Jacques Eric Gottenberg, MD
- Recruiting
Hopital Foch
Suresnes
Felix Ackermann, MD
- Recruiting
CHU Toulouse
Toulouse
Stanislas Faguer, MD
- Recruiting
CHU Tours
Tours
Alexandra Audemard, MD
- Recruiting
CHU Valenciennes
Valenciennes
Thomas Quemeneur, MD
About this study
Official title: Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)
Cryoglobulinemia vasculitis (CV) is a systemic immune-mediated small vessel vasculitis. Rituximab proved effective on main vasculitis signs, with a complete clinical response of 65%. However, CV relapse is noted in up to 40% of patients. Following rituximab, serum Blys concentration significantly increased and may favor relapses. Tribeca is a multicentre randomized controled study comparing safety and efficacy of belimumab to placebo in non infectious cryoglobulinemia vasculitis.
- Conditions
- Vasculitis, Cryoglobulinemia
- Being tested
- Belimumab, Placebo
- Keywords
- Belimumab, Vasculitis, Cryoglobulinemia, Non-infectious
- Medical subject headings
- Vasculitis, Cryoglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelimumabDrug
Belimumab administered subcutaneously 200mg weekly from week 1 to week 24.
Both arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive:
- 30 mg/day week (W)0-W2,
- 20 mg/day W2-W4
- 15 mg/day W4-W6,
- 10 mg/day W6-W8,
- 5 mg/day W8-W10
Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion.
Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity.
PlaceboDrug
Both arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive:
- 30 mg/day week (W)0-W2,
- 20 mg/day W2-W4
- 15 mg/day W4-W6,
- 10 mg/day W6-W8,
- 5 mg/day W8-W10
Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion.
Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity.
| Study group | Role | What they receive |
|---|---|---|
| Belimumab | Experimental | Belimumab administered subcutaneously 200mg weekly from week 1 to week 24. Receives: Drug: Belimumab |
| Placebo | Placebo comparator | Placebo of Belimumab administered subcutaneously weekly from week 1 to week 24. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response rate at week 25 with corticosteroid withdrawal at week 12
Complete clinical response is defined by remission of all affected organs involved at baseline and the absence of clinical relapse.
- Skin and articular remissions
- Renal remission
- Neurological remission
- Digestive remission
- Cardiac remission
- Central nervous system remission
- Pulmonary remission
Measured: Week 25
Secondary outcomes (28)
Safety W25
Frequency and severity of adverse clinical events
Measured: Week 25
Safety W48
Frequency and severity of adverse clinical events
Measured: Week 48
Response W13
The complete clinical response is defined by the remission of all affected organs involved at baseline and the absence of clinical relapse.
Partial clinical response The partial clinical response is defined by the improvement and / or remission of more than half of the organ involvement present at baseline and the absence of clinical relapse.
No clinical response Patients with no clinical response at W4 will be defined by worsening of ulcers or cutaneous necrosis, worsening peripheral neurological involvement or by persistence of active renal involvement defined by persistence of proteinuria> 1.5 g / 24h or proteinuria/creatinuria <150 mg/mmol).
Measured: Week 13
Response W25
The complete clinical response is defined by the remission of all affected organs involved at baseline and the absence of clinical relapse.
Partial clinical response The partial clinical response is defined by the improvement and / or remission of more than half of the organ involvement present at baseline and the absence of clinical relapse.
No clinical response Patients with no clinical response at W4 will be defined by worsening of ulcers or cutaneous necrosis, worsening peripheral neurological involvement or by persistence of active renal involvement defined by persistence of proteinuria> 1.5 g / 24h or proteinuria/creatinuria <150 mg/mmol).
Measured: Week 25
Response W48
The complete clinical response is defined by the remission of all affected organs involved at baseline and the absence of clinical relapse.
Partial clinical response The partial clinical response is defined by the improvement and / or remission of more than half of the organ involvement present at baseline and the absence of clinical relapse.
No clinical response Patients with no clinical response at W4 will be defined by worsening of ulcers or cutaneous necrosis, worsening peripheral neurological involvement or by persistence of active renal involvement defined by persistence of proteinuria> 1.5 g / 24h or proteinuria/creatinuria <150 mg/mmol).
Measured: Week 48
Rate of cryoglobulinemia clearance W13
cryoglobulinemia clearance
Measured: Week 13
Rate of cryoglobulinemia clearance W25
cryoglobulinemia clearance
Measured: Week 25
Rate of cryoglobulinemia clearance W48
cryoglobulinemia clearance
Measured: Week 48
rheumatoid factor activity W13
negativation of rheumatoid factor activity
Measured: Week 13
rheumatoid factor activity W25
negativation of rheumatoid factor activity
Measured: Week 25
rheumatoid factor activity W48
negativation of rheumatoid factor activity
Measured: Week 48
C4 complement level W13
normalization of C4 complement level
Measured: Week 13
C4 complement level W25
normalization of C4 complement level
Measured: Week 25
C4 complement level W48
normalization of C4 complement level
Measured: Week 48
Early failures
Rate of early failures (non clinical response at W5) Patients with no clinical response at W4 will be defined by worsening of ulcers or cutaneous necrosis, worsening peripheral neurological involvement or by persistence of active renal involvement defined by persistence of proteinuria> 1.5 g / 24h or proteinuria/creatinuria <150 mg/mmol,).
Measured: Week 5
Clinical relapse rate W48
Relapse is defined as de novo appearance or recurrence of a manifestation of cryoglobulinemia vasculitis
Measured: Week 48
Prednisone W25
Cumulative dose of prednisone
Measured: Week 25
Prednisone W48
Cumulative dose of prednisone
Measured: Week 48
Gammaglobulin
Measured: Baseline
Gammaglobulin
Measured: Week 48
CD19+
Measured: Baseline
CD19+
Measured: Week 48
Quality of life W25
Quality of life score SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software for the commercial version, but no special software is needed for the RAND-36 version. Pricing depends on the number of scores that the researcher needs to calculate.
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
Measured: Week 25
Quality of life W48
Quality of life score SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software for the commercial version, but no special software is needed for the RAND-36 version. Pricing depends on the number of scores that the researcher needs to calculate.
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
Measured: Week 48
Infections
Rate of infections
Measured: Week 48
BVAS activity W13
BVAS activity score as defined in Flossmann, Oliver, et al. "Development of comprehensive disease assessment in systemic vasculitis." Postgraduate medical journal 84.989 (2008): 143-152.
Measured: Week 13
BVAS activity W25
BVAS activity score as defined in Flossmann, Oliver, et al. "Development of comprehensive disease assessment in systemic vasculitis." Postgraduate medical journal 84.989 (2008): 143-152.
Measured: Week 25
BVAS activity W48
BVAS activity score as defined in Flossmann, Oliver, et al. "Development of comprehensive disease assessment in systemic vasculitis." Postgraduate medical journal 84.989 (2008): 143-152.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start20 Oct 2021
- Primary completion20 Apr 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629144
- Sponsor's protocol ID
- APHP180351
- Acronym
- TRIBECA
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)
- ClinicalTrials.gov ID
- NCT04629144
- Acronym / sponsor ID
- TRIBECA / APHP180351
- Conditions
- Vasculitis, Cryoglobulinemia
- Keywords
- Belimumab, Vasculitis, Cryoglobulinemia, Non-infectious
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 16 Nov 2020 (actual)
- 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.
Cryoglobulinemia vasculitis (CV) is a systemic immune-mediated small vessel vasculitis. Rituximab proved effective on main vasculitis signs, with a complete clinical response of 65%. However, CV relapse is noted in up to 40% of patients. Following rituximab, serum Blys concentration significantly increased and may favor relapses. Tribeca is a multicentre randomized controled study comparing safety and efficacy of belimumab to placebo in non infectious cryoglobulinemia vasculitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belimumab | Experimental | Drug: BelimumabBelimumab administered subcutaneously 200mg weekly from week 1 to week 24. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of Belimumab administered subcutaneously weekly from week 1 to week 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The eligibility criteria will be checked at the inclusion/randomization visit. Patients meeting the following criteria may be included in the study:
- Age > 18 years
- Written inform consent
- Active mixed cryoglobulinemia vasculitis, at initiation of rituximab, define by a. a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement , b. history of positive cryoglobulinemia and/or positive Rheumatoid factor associated with low C4 complement level , and/or a monoclonal component (IgM Kappa) and/or a histologal proof of vasculitis in the affected organs
- Affiliated to National French social security system
Key exclusion criteria (27 listed)
- Patient with a vasculitis unrelated to cryoglobulinemia
- Patient with non active cryoglobulinemia vasculitis, at initiation of rituximab. Patients with mixed inactive vasculitis following rituximab administration may be included.
- Excluded concomitant medications:
- Have a history of malignant neoplasm within the last 5 years, other than carcinoma in situ of the cervix or excised basal cell, squamous cell carcinoma of the skin and low grade hemopathy with no indication for a specific treatment
- Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
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 |
|---|---|---|
| BelimumabBelimumab administered subcutaneously 200mg weekly from week 1 to week 24. Both arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive: * 30 mg/day week (W)0-W2, * 20 mg/day W2-W4 * 15 mg/day W4-W6, * 10 mg/day W6-W8, * 5 mg/day W8-W10 Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion. Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity. | Drug | Belimumab |
| PlaceboBoth arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive: * 30 mg/day week (W)0-W2, * 20 mg/day W2-W4 * 15 mg/day W4-W6, * 10 mg/day W6-W8, * 5 mg/day W8-W10 Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion. Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity. | Drug | Placebo |
Primary outcome
Complete clinical response rate at week 25 with corticosteroid withdrawal at week 12
Time frame: Week 25
Complete clinical response is defined by remission of all affected organs involved at baseline and the absence of clinical relapse. * Skin and articular remissions * Renal remission * Neurological remission * Digestive remission * Cardiac remission * Central nervous system remission * Pulmonary remission
28 secondary outcomes
Safety W25
Time frame: Week 25
Safety W48
Time frame: Week 48
Response W13
Time frame: Week 13
Response W25
Time frame: Week 25
Response W48
Time frame: Week 48
Rate of cryoglobulinemia clearance W13
Time frame: Week 13
Rate of cryoglobulinemia clearance W25
Time frame: Week 25
Rate of cryoglobulinemia clearance W48
Time frame: Week 48
rheumatoid factor activity W13
Time frame: Week 13
rheumatoid factor activity W25
Time frame: Week 25
rheumatoid factor activity W48
Time frame: Week 48
C4 complement level W13
Time frame: Week 13
C4 complement level W25
Time frame: Week 25
C4 complement level W48
Time frame: Week 48
Early failures
Time frame: Week 5
Clinical relapse rate W48
Time frame: Week 48
Prednisone W25
Time frame: Week 25
Prednisone W48
Time frame: Week 48
Gammaglobulin
Time frame: Baseline
Gammaglobulin
Time frame: Week 48
CD19+
Time frame: Baseline
CD19+
Time frame: Week 48
Quality of life W25
Time frame: Week 25
Quality of life W48
Time frame: Week 48
Infections
Time frame: Week 48
BVAS activity W13
Time frame: Week 13
BVAS activity W25
Time frame: Week 25
BVAS activity W48
Time frame: Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
20 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 Belimumab in people with Vasculitis and Cryoglobulinemia, run by Assistance Publique - Hôpitaux de Paris at 20 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 15 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Saadoun, MD PhD (142499742 ext. 33, david.saadoun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical response rate at week 25 with corticosteroid withdrawal at week 12 (time frame: Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2024.