Polymyalgia RheumaticaPhase 3NCT03263715
A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)
A Phase 3 study testing Tocilizumab Prefilled Syringe [Actemra] and Glucocorticoids in people with Polymyalgia Rheumatica, run by Medical University of Vienna at 3 sites in Austria.
Trial summary
The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind, controlled fashion, focussing on glucocorticoid-free remission of disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Tocilizumab Prefilled Syringe [Actemra] and Glucocorticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 3 sitesAustria
- Study dates
- 24 Nov 2017to 2 Jun 2020
- Phase
- Phase 3
- 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
- Diagnosis of PMR as confirmed by the investigator at screening and at baseline, fulfilment (also in retrospect) of the provisional 2012 ACR- EULAR classification criteria
- Diagnosis of PMR established at, or up to 2 weeks before the screening visit
- GC naïve or on GC treatment for a maximum of 2 weeks at screening with an initial dose between 12.5 and 25mg/day prednisone
- Willing and able to receive oral prednisone 20mg/day at randomization and to follow a pre-specified tapering regimen
- Willing to receive treatment for prevention of GC-induced bone loss
- No evidence of active infection with Mycobacterium tuberculosis (screening performed according to national guidelines) and willing to take TB prophylaxis in case of evidence of latent TB
Show all 10Show fewer
- Willing and being able to understand and follow the study procedures
- Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)
- Written informed consent.
- Female and Male subjects from 18 years old and higher
Who cannot join
- Evidence of GCA (cranial or large vessel) as indicated by unequivocal clinical symptoms (except PMR), imaging and/or biopsy results. Routine screening of eligible PMR patients for GCA with imaging methods or temporal artery biopsy is not recommended
- GC treatment of PMR >2 weeks
- Conditions other than PMR requiring continuous or intermittent treatment with oral or parenteral GCs or parenteral administration of GCs, unless the last exposure to GCs was >1 months before screening
- Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
Show all 35Show fewer
- Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20
- Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- Previous treatment with Tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case-by-case basis)
- Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn ́s disease)
- Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN
- Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL (168 μmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study, if their estimated glomerular filtration rates (GFR) are > 30
- Total Bilirubin > ULN
- Any history of recent serious bacterial, viral, fungal, or other opportunistic infections
- Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C
- Positive QuantiFERON TB test, history of Tuberculosis, or active Tuberculosis-infection, without at least 4 weeks of adequate therapy for Tuberculosis
- Active infection with EBV as defined by EBV viral load > 10,000 copies per mL of whole blood
- Any of the following hematologic abnormalities, confirmed by repeat tests:
- White blood count < 3,000/μL or > 14,000/μL;
- Lymphocyte count < 500/ μL;
- Platelet count < 100,000/μL;
- Hemoglobin < 8.0 g/dL; or
- Neutrophil count < 2,000 cells/μL
- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
- Any medical or psychological condition that in the opinion of the Principal Investigator would interfere with safe completion of the trial
- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- Pregnant women or nursing (breast feeding) mothers
- Patients with reproductive potential not willing to use an effective method of contraception
- History of alcohol, drug or chemical abuse within 1 year prior to screening
- Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
- Patients with lack of peripheral venous access
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie
Graz, 8036
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
Krankenhaus Hietzing, 2. Medizinische Abteilung
Vienna, 1130
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)
The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind, controlled fashion, focussing on glucocorticoid-free remission of disease.
Read the detailed description
Background. Polymyalgia rheumatica is an inflammatory rheumatic disease of the elderly, with a usually rapid response to intermediate-doses of glucocorticoids (GCs). In many patients, relapses occur upon its dose reduction or cessation. Given the patients' age and the adverse event profile of GCs, steroid- free remission is the most desired target in patients with PMR, but typical GC sparing agents are often insufficient. Case series and small open studies suggested an excellent effectiveness of tocilizumab, an inhibitor of the Interleukin 6-receptor.
Objective. To assess the efficacy and safety of a tocilizumab-based regimen compared with placebo on top of rapidly tapered GC treatment in a double-blind, controlled fashion, focussing on GC-free remission of disease.
Methods. In this double-blind, parallel group study, 32 patients with PMR will be recruited from three rheumatology centres and will be randomised in a 1:1 ratio to tocilizumab or placebo over the course of 16 weeks, accompanied by a rapid tapering GC scheme over 11 weeks in both arms. The primary endpoint is GC-free remission at week 16, and follow-up will be performed until week 24 for safety and sustained efficacy. Patients will receive either the subcutaneous preparation of 162 mg tocilizumab weekly or matching placebo injections.
Expected Results. In case of a positive result of this study, the benefits for patients with new-onset PMR will manifest in a reduction of the burden of GC intake in this elderly population with increased risk of GC-related adverse events.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Tocilizumab Prefilled Syringe [Actemra], Placebos, Glucocorticoids
- Keywords
- Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid, Glucocorticoid-Sparing
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab Prefilled Syringe [Actemra]Drug
Also called Actemra
Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.
PlacebosDrug
Weekly administration of Placebo subcutaneous from Baseline to Week 16.
GlucocorticoidsDrug
Rapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Tocilizumab-based regimen (Tocilizumab Prefilled Syringe [Actemra] 162 mg s.c. administered weekly) on top of rapidly tapered Glucocorticoid [Glucocorticoids] Receives: Drug: Tocilizumab Prefilled Syringe [Actemra]; Drug: Glucocorticoids |
| Placebo | Placebo comparator | Placebo [Placebos] and rapidly tapered Glucocorticoid [Glucocorticoids] treatment Receives: Drug: Placebos; Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in GC free remission at week 16
Proportion of subjects in GC free remission at week 16
Measured: Week 16
Secondary outcomes (13)
Cumulative prednisone doses at weeks 12, 16 and 24
Cumulative prednisone doses at weeks 12, 16 and 24
Measured: Week 12, 16, 24
Number of flares per patient at weeks 12, 16 and 24
Number of flares per patient at weeks 12, 16 and 24
Measured: Week 12, 16, 24
Time to first and second flare
Time to first and second flare
Measured: 24 Weeks
Patient reported outcomes including SF-36
Patient reported outcomes including SF-36
Measured: 24 Weeks
Patient reported outcomes including FACIT-Fatigue
Patient reported outcomes including FACIT-Fatigue
Measured: 24 Weeks
Patient reported outcomes including HAQ
Patient reported outcomes including HAQ
Measured: 24 Weeks
Patient reported outcomes including Patient Global Assessment of disease (PGA)
Patient reported outcomes including Patient Global Assessment of disease (PGA)
Measured: 24 Weeks
Patient reported outcomes including Patient Assessment of pain
Patient reported outcomes including Patient Assessment of pain
Measured: 24 Weeks
Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)
Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)
Measured: 24 Weeks
Investigator reported outcomes including Duration and severity of Morning Stiffness
Investigator reported outcomes including Duration and severity of Morning Stiffness
Measured: 24 Weeks
Investigator reported outcomes including Elevation of upper limbs
Investigator reported outcomes including Elevation of upper limbs
Measured: 24 Weeks
Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters
Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters
Measured: 24 Weeks
Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 5mg/L) at week 24
Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 5mg/L) at week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start24 Nov 2017
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
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 Polymyalgia RheumaticaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Aletaha, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263715
- Sponsor's protocol ID
- PMR-SPARE
- Other IDs
- 2016-004990-42, 2016
- Status last verified
- Jan 2021
- First submitted
- 17 Aug 2017
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonelli M, Radner H, Kerschbaumer A, Mrak D, Durechova M, Stieger J, Husic R, Mandl P, Smolen JS, Dejaco C, Aletaha D. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial. Ann Rheum Dis. 2022 Jun;81(6):838-844. doi: 10.1136/annrheumdis-2021-221126. Epub 2022 Feb 24.
PubMed 35210264
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)
- ClinicalTrials.gov ID
- NCT03263715
- Acronym / sponsor ID
- PMR-SPARE
- Conditions
- Polymyalgia Rheumatica
- Keywords
- Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid, Glucocorticoid-Sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 28 Aug 2017 (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.
The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind, controlled fashion, focussing on glucocorticoid-free remission of disease.
Detailed description
Background. Polymyalgia rheumatica is an inflammatory rheumatic disease of the elderly, with a usually rapid response to intermediate-doses of glucocorticoids (GCs). In many patients, relapses occur upon its dose reduction or cessation. Given the patients' age and the adverse event profile of GCs, steroid- free remission is the most desired target in patients with PMR, but typical GC sparing agents are often insufficient. Case series and small open studies suggested an excellent effectiveness of tocilizumab, an inhibitor of the Interleukin 6-receptor.
Objective. To assess the efficacy and safety of a tocilizumab-based regimen compared with placebo on top of rapidly tapered GC treatment in a double-blind, controlled fashion, focussing on GC-free remission of disease.
Methods. In this double-blind, parallel group study, 32 patients with PMR will be recruited from three rheumatology centres and will be randomised in a 1:1 ratio to tocilizumab or placebo over the course of 16 weeks, accompanied by a rapid tapering GC scheme over 11 weeks in both arms. The primary endpoint is GC-free remission at week 16, and follow-up will be performed until week 24 for safety and sustained efficacy. Patients will receive either the subcutaneous preparation of 162 mg tocilizumab weekly or matching placebo injections.
Expected Results. In case of a positive result of this study, the benefits for patients with new-onset PMR will manifest in a reduction of the burden of GC intake in this elderly population with increased risk of GC-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: Tocilizumab Prefilled Syringe [Actemra], Drug: GlucocorticoidsTocilizumab-based regimen (Tocilizumab Prefilled Syringe [Actemra] 162 mg s.c. administered weekly) on top of rapidly tapered Glucocorticoid [Glucocorticoids] |
| Placebo | Placebo comparator | Drug: Placebos, Drug: GlucocorticoidsPlacebo [Placebos] and rapidly tapered Glucocorticoid [Glucocorticoids] treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of PMR as confirmed by the investigator at screening and at baseline, fulfilment (also in retrospect) of the provisional 2012 ACR- EULAR classification criteria
- Diagnosis of PMR established at, or up to 2 weeks before the screening visit
- GC naïve or on GC treatment for a maximum of 2 weeks at screening with an initial dose between 12.5 and 25mg/day prednisone
- Willing and able to receive oral prednisone 20mg/day at randomization and to follow a pre-specified tapering regimen
- Willing to receive treatment for prevention of GC-induced bone loss
Key exclusion criteria (35 listed)
- Evidence of GCA (cranial or large vessel) as indicated by unequivocal clinical symptoms (except PMR), imaging and/or biopsy results. Routine screening of eligible PMR patients for GCA with imaging methods or temporal artery biopsy is not recommended
- GC treatment of PMR >2 weeks
- Conditions other than PMR requiring continuous or intermittent treatment with oral or parenteral GCs or parenteral administration of GCs, unless the last exposure to GCs was >1 months before screening
- Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
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 |
|---|---|---|
| Tocilizumab Prefilled Syringe [Actemra]Also: ActemraWeekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16. | Drug | Tocilizumab |
| PlacebosWeekly administration of Placebo subcutaneous from Baseline to Week 16. | Drug | Placebo |
| GlucocorticoidsRapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg | Drug | Placebo, Tocilizumab |
Primary outcome
Proportion of subjects in GC free remission at week 16
Time frame: Week 16
Proportion of subjects in GC free remission at week 16
13 secondary outcomes
Cumulative prednisone doses at weeks 12, 16 and 24
Time frame: Week 12, 16, 24
Number of flares per patient at weeks 12, 16 and 24
Time frame: Week 12, 16, 24
Time to first and second flare
Time frame: 24 Weeks
Patient reported outcomes including SF-36
Time frame: 24 Weeks
Patient reported outcomes including FACIT-Fatigue
Time frame: 24 Weeks
Patient reported outcomes including HAQ
Time frame: 24 Weeks
Patient reported outcomes including Patient Global Assessment of disease (PGA)
Time frame: 24 Weeks
Patient reported outcomes including Patient Assessment of pain
Time frame: 24 Weeks
Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)
Time frame: 24 Weeks
Investigator reported outcomes including Duration and severity of Morning Stiffness
Time frame: 24 Weeks
Investigator reported outcomes including Elevation of upper limbs
Time frame: 24 Weeks
Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters
Time frame: 24 Weeks
Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 5mg/L) at week 24
Time frame: Week 24
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 22 Jan 2021.
- Derived from this study: PubMed 35210264Bonelli M, Radner H, Kerschbaumer A, Mrak D, Durechova M, Stieger J, Husic R, Mandl P, Smolen JS, Dejaco C, Aletaha D. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial. Ann Rheum Dis. 2022 Jun;81(6):838-844. doi: 10.1136/annrheumdis-2021-221126. Epub 2022 Feb 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab Prefilled Syringe [Actemra] and Glucocorticoids in people with Polymyalgia Rheumatica, run by Medical University of Vienna at 3 sites in Austria.
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 35 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects in GC free remission at week 16 (time frame: Week 16). 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 NCT03263715, 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 22 Jan 2021.