Overview
Sponsor-declared trial summary
Rheumatoid arthritis
The main objective is to investigate the difference in mean time weighted Disease Activity Score in 28 joints, including erythrocyte sedimentation rate (DAS28-ESR) in patients with RA with serum trough concentrations higher than 15 mg/L who are randomly assigned to continuation of the standard dose or to increase dosin…
Key facts
- Sponsor
- Reade revalidatie & reumatologie centrum te Amsterdam
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-01-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520513-30-00
- EudraCT number
- 2018-004605-57
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic
The main objective is to investigate the difference in mean time weighted Disease Activity Score in 28 joints, including erythrocyte sedimentation rate (DAS28-ESR) in patients with RA with serum trough concentrations higher than 15 mg/L who are randomly assigned to continuation of the standard dose or to increase dosing interval to every two weeks.
Conditions and MedDRA coding
Rheumatoid arthritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Rheumatoid arthritis according to the ACR 1987 or 2010 criteria
- Current use of subcutaneous tocilizumab 162 mg weekly , for at least the last 6 months
- The treating rheumatologist is convinced of the benefit of tocilizumab continuation
- No changes in the treatment with glucocorticoids and DMARDs such as methotrexate in the past three months
- Written informed consent
Exclusion criteria 1
- A scheduled surgery in the next 52 weeks or other pre-planned reasons for treatment discontinuation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective of this study is to investigate the difference in mean time weighted DAS28 after 28 weeks between concentration-guided dose reduction and standard dosing. This analysis will be based on the non-inferiority principle, since we expect no worse outcome for patients in whom the dosing interval will be adjusted compared to patients who continue on the regular tocilizumab dose. As explained in the sample size calculation, the mean time weighted DAS28 is expected to be 2.8, with a
Secondary endpoints 11
- We will look at the difference in mean time weighted DAS28 after 52 weeks between the two treatment groups.
- The difference in CDAI, SDAI, and HAQ score after 28 weeks and 52 weeks between the two treatment groups
- The direct medical costs of TDM compared to the standard treatment regimen
- The difference in number of flares between the two treatment arms at 28 and 52 weeks
- The number and severity of adverse events in both treatment arms
- The difference in drug levels in the intervention group between week 0 and 52
- The change in drug levels from baseline after 52 weeks of intervention
- The relationship between dose, drug concentration, and clinical disease activity
- The therapeutic range of tocilizumab
- The development of a pharmacokinetic model resulting in a dashboard system
- The perspective of the patients about optimizing their dose with therapeutic drug monitoring
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP176238 · ATC
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 162
- Max total dose
- 162
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — TOCILIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Reade revalidatie & reumatologie centrum te Amsterdam
- Sponsor organisation
- Reade revalidatie & reumatologie centrum te Amsterdam
- Address
- Admiraal Helfrichstraat 1
- City
- Amsterdam
- Postcode
- 1056 AA
- Country
- Netherlands
Scientific contact point
- Organisation
- Reade revalidatie & reumatologie centrum te Amsterdam
- Contact name
- Maureen Leeuw
Public contact point
- Organisation
- Reade revalidatie & reumatologie centrum te Amsterdam
- Contact name
- Maureen Leeuw
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 98 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Onderzoeksprotocol 2025-520513-30-00 | 6 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TODORA adult | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC Tocilizumab | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-07 | Netherlands | Acceptable 2025-01-16
|
2025-01-16 |