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Giant Cell ArteritisPhase 2MTXinGCANCT05623592

Methotrexate as Remission Maintenance Therapy After Remission-Induction With Tocilizumab and Glucocorticoids in Giant Cell Arteritis

A Phase 2 study testing Methotrexate and Sodium chloride in people with Giant Cell Arteritis, run by University of Bonn at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The standard treatment for Giant Cell arteritis (GCA) is Glucocorticoids(GC), even if GC-related adverse events are commonly occuring. Therefore, other practises for reducing relapses and cumulative GC-doses are needed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Giant Cell Arteritis
What is being tested?
Methotrexate and Sodium chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteGermany
Study dates
23 Nov 2022to Nov 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

  • Subjects male or female, aged ≥18 years
  • Written informed consent of the capable subject for voluntary participation in the study.
  • Diagnosis of GCA as confirmed by the investigator fulfilment (also in retrospect) of the proposed extended 1990 classification criteria for GCA .
  • Previous treatment with glucocorticoids and tocilizumab for new or relapsing GCA
  • GCA patients who have been treated with tocilizumab and in whom discontinuation of tocilizumab therapy has been decided by the treating rheumatologist, within standard treatment at the department of rheumatology are eligible.
  • total tocilizumab therapy should have been at least 6 months before inclusion.
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  • Patients should be in stable remission (defined as the absence of signs or symptoms of GCA and normal C-Reactive Protein (<1mg/dl), off glucocorticoids for at least 1 months at screening.
  • Willing and able to inject methotrexate or placebo subcutaneously at randomization
  • Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)

Who cannot join

  • Severe renal (glomerular filtration rate <30/min) failure
  • Conditions other than GCA requiring continuous or intermittent treatment with oral or parenteral Glucocorticoids unless the last exposure to Glucocorticoids was >1 months before screening
  • Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
  • Current treatment with any other conventional, biologic or targeted synthetic DMARD except tocilizumab
  • Elevation of transaminases above three times the norm
  • Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to participation in this clinical trial.
  • Pregnant or breast feeding women
  • Contraindications for therapy with Methotrexate, as indicated in the summary of product characteristics

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medical Clinic and Polyclinic III Internal medicine Oncology, Hematology University Hospital Bonn, Rheumatology and Clinical Immunology

    Bonn

Other trials in Germany

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy After Remission-Induction Therapy With Tocilizumab and Glucocorticoids in Subjects With Giant Cell Arteritis

The standard treatment for Giant Cell arteritis (GCA) is Glucocorticoids(GC), even if GC-related adverse events are commonly occuring. Therefore, other practises for reducing relapses and cumulative GC-doses are needed. Currently, the Interleukin-6-inhibitor tocilizumab is used in combination with GC to achieve higher remission rates and lower cumulative GC-doses. The use of tocilizumab also has some disadvantages. One is the increased susceptibility to infections. On top of that, a long-term follow-up of the phase II study by Villiger et al. showed a 55% relapse-rate after discontinuation of intravenous tocilizumab after a median of five months.

Studies have also shown that methotrexate(MTX) in combination with GC was able to prevent relapses and reduce cumulative GC doses.

The aim of the study is to evaluate whether MTX is superior to placebo to prevent relapses in subjects with GCA after Remission-Induction Therapy with Glucocorticoids and Tocilizumab. Our hypothesis is that Methotrexate can maintain remission, once stable remission has been induced by GC and Tocilizumab and will prevent the occurrence of relapses.

Being tested
Methotrexate, Sodium chloride
Keywords
Giant cell arteritis, Methotrexate, Tocilizumab, Glucocorticoids, Remission maintenance, Vasculitis, Rheumatic disease, Ultrasound
Medical subject headings
Giant Cell Arteritis, Vasculitis, Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    17,5/15/10 mg Methotrexate subcutaneously

  • Sodium chlorideDrug

    Sodium chloride subcutaneously

Study groups in NCT05623592
Study groupRoleWhat they receive
MethotrexateExperimentalThe patient will be treated for 12 months weekly with methotrexate. Methotrexate will be provided at a dose of 17.5mg as a pre-filled syringe for self-injection. A dose reduction to 15 mg/week in case of intolerance, elevated liver enzymes >3x upper limit of normal or to 10 mg/week if glomerular filtration rate <50/min will be possible. If glomerular filtration rate <30/min, termination of treatment.
Receives: Drug: Methotrexate
PlaceboPlacebo comparatorPatients receive sodium chloride as a placebo subcutaneously. It will be administered in the form of a pre-filled syringe for self-injection once a week for 12 months.
Receives: Drug: Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to relapse during the 12 months treatment period

    Measured: 12 months

Secondary outcomes (14)

  1. Cumulative prednisone doses at months 6, 12 and 18

    Measured: 18 months

  2. Number of relapses per patient during the 12 months treatment period

    Measured: 12 months

  3. Time to first, second and third relapse after randomization

    Measured: 18 months

  4. Percentage of patients with a relapse at month 6 and 18 after discontinuation of Tocilizumab

    Measured: 18 months

  5. Health-related quality of life: Short Form-36

    The possible score ranges from 0 to 100 points, where 0 points represent the greatest possible health limitation, while 100 points represent no health limitation at all

    Measured: 18 months

  6. Self-reported fatigue : FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue Scale)

    The possible score ranges from 0 to 52 points. The higher this value, the better the quality of life.

    Measured: 18 months

  7. Patient Global Assessment of disease activity (PGA)

    The possible score ranges from 0 to 100 points, where 0 points represent the lowest disease activity and 100 the highest.

    Measured: 18 months

  8. Patient Assessment of pain

    The possible score ranges from 0 to 100 points, where 0 points represent the least pain intensity and 100 the most pain intensity

    Measured: 18 months

  9. Investigator reported Evaluator Global Assessment of disease activity (EGA)

    The possible score ranges from 0 to 100 points, where 0 points represent the lowest disease activity and 100 the highest.

    Measured: 18 months

  10. Occurrence of symptoms and signs related to Giant cell arteritis

    Measured: 18 months

  11. Number of vasculitic vessels and change of intima-media-values of temporal and axillary arteries

    Measured: 18 months

  12. Prevalence of aortitis at baseline and month 12 and 18 in MRI

    Measured: 18 months

  13. Proportion of subjects with increased Erythrocyte Sedimentation Rate (>20mm/h) and C-Reactive Protein levels (> 10mg/L)

    Measured: 18 months

  14. Occurrence of adverse events and serious adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start23 Nov 2022
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623592
Sponsor's protocol ID
MED3-201802
Other IDs
EU-CT No: 2022-501058-12-00, DRKS-ID: DRKS00030571
Acronym
MTXinGCA
Status last verified
Apr 2024
First submitted
8 Nov 2022
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Kreis L, Dejaco C, Schmidt WA, Nemeth R, Venhoff N, Schafer VS. The Meteoritics Trial: efficacy of methotrexate after remission-induction with tocilizumab and glucocorticoids in giant cell arteritis-study protocol for a randomized, double-blind, placebo-controlled, parallel-group phase II study. Trials. 2024 Jan 15;25(1):56. doi: 10.1186/s13063-024-07905-4.

    PubMed 38225579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methotrexate and Sodium chloride in people with Giant Cell Arteritis, run by University of Bonn at 1 site in Germany.

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 9 inclusion and 8 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

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?

Time to relapse during the 12 months treatment period (time frame: 12 months). 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 NCT05623592, 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 10 Apr 2024.

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