Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
180
Countries
1
Sites
2
Rheumatoid arthritis
The co-primary objective is to evaluate cs-/b-/tsDMARD tapering (tapering group) compared to continuation of DMARDs as usual care (control group) based on patient preference in elderly patients (≥70 years) with RA in sustained LDA. The co-primary endpoint at 24 months will be met if: A. Superiority in ≥50% accumulate…
Key facts
- Sponsor
- Aalborg University Hospital, Aalborg University Hospital
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-07-06
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The co-primary objective is to evaluate cs-/b-/tsDMARD tapering (tapering group) compared to continuation of DMARDs as usual care (control group) based on patient preference in elderly patients
(≥70 years) with RA in sustained LDA. The co-primary endpoint at 24 months will be met if:
A. Superiority in ≥50% accumulated cs- and/or b-/tsDMARD dose reduction is demonstrated in the tapering group compared to the control group. The accumulated DMARD dose reduction will be calculated as the mean percentage reduction across cs- and b-/tsDMARD treatments relative to the baseline dosing. E.g., 25% reduction in csDMARD and 25% reduction in b-/tsDMARD = 25% total DMARD reduction, 100% reduction in cs-DMARD and 0% in b-/tsDMARD = 50% total reduction, and 75% reduction in cs-DMARD and 50% in b-/ts-DMARD = 63% total reduction.
B. Equivalent disease activity is maintained measured by the average Disease Activity Score-28-C-Reactive Protein score (DAS28-CRP) across the 24-months observation period with predefined equivalence margins of ±0.5.
Secondary objectives 2
- Secondary objectives are to compare the effect of tapering versus control after 24 months on: 1) Patient-reported outcome measures (PROMs): visual analogue scale (VAS) pain, fatigue, and patient global, Multidimensional Health Assessment Questionnaire (MD-HAQ), Patient Acceptable Symptom State (PASS), and EuroQol-5 Dimension-5 Levels index (EQ-5D-5L). 2) Clinical objectives: tender joint count, swollen joint count, C-reactive protein (CRP), physician VAS global, in remission (DAS28-CRP <2.6), in LDA (DAS28-CRP <3.2), and in American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Boolean 2.0 remission (tender joint count ≤1, swollen joint count ≤1, CRP ≤10 mg/L, and VAS patient global ≤20 [on a 0–100 scale] (18)). 3) Geriatric outcomes: Activities of Daily Living (ADL) measured by the Katz ADL scale, falls (number of falls), fragility measured by the Clinical Fragility Scale (CFS), comorbidities evaluated by the Rheumatic Disease Comorbidity Index (RDCI), institutionalisation (living at a nursing home or similar), hospitalisation (proportion of patients admitted to the hospital, number of hospitalisations per patient). 4) Safety objectives: arthritis flare, persistent arthritis flare (≥12 weeks), antibiotic-treated non-serious infections, serious infections, serious cardiovascular events, malignancy, or death.
- Tertiary (exploratory) objectives will be reported in secondary manuscripts and include: 1) • Sub-group analyses on the primary objective in order to assess potential differences between a) Women vs men, b) 70-79 years of age vs ≥80 years of age, and c) csDMARD treatment only vs treatment with b-/tsDMARDs. 2) Possible baseline predictors for NOT achieving successful tapering at 24 months based on data from the tapering group. Non-successful tapering was pre-defined as: achieved <50% DMARD reduction or not in LDA or need for switch to another DMARD. 3) Cost-effectiveness for the 24 months trial period. 4) Long-term effectiveness of the interventions at year five including patient-quality-of-life, safety, and cost-effectiveness.
Conditions and MedDRA coding
Rheumatoid arthritis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Study period (baseline to 24 months) Patients will, after written informed consent is obtained, be allocated based on preference to either:
A) Tapering group: gradually tapering of cs-/b-/tsDMARDs by lowering the dose or expanding the dosing interval at the discretion of the treating physician and the patient e.g. by 25-50% reduction every 6 month.
B) Control group: continuation of cs-/b-/tsDMARDs as usual care, i.e., maintain the baseline dosing but upon patient request a minor dose adjustment is permitted in accordance with usual clinical practice.
After the primary endpoint assessment at 24 months, patients in the control group are allowed to taper their cs-/b-/tsDMARDs more aggressively at the discretion of the physician and the patient.
|
2 | None | Tapering group: Gradually tapering of cs-/b-/tsDMARDs by lowering the dose or expanding the dosing interval at the discretion of the treating physician and the patient e.g. by 25-50% reduction every 6 month. Control group: Continuation of cs-/b-/tsDMARDs as usual care, i.e., maintain the baseline dosing but upon patient request a minor dose adjustment is permitted in accordance with usual clinical practice. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Inclusion criteria are: • Able to read and understand information material in Danish. • ≥70 years of age. • Diagnosed with RA according to national guidelines. • Treated with cs-/b-/tsDMARD in stable dosage, i.e., no dose alterations during ≥12 months. • In LDA (DAS28-CRP <3.2) during ≥12 months measured by registrations in DANBIO. • No inflammatory joint activity during the past 12 months judged by the investigator. • Stable, low-dose prednisolone (≤5 mg/day) or no prednisolone during ≥12 months.
Exclusion criteria 1
- Exclusion criteria are: • Inability to provide informed consent or unwilling to comply with the trial protocol. • DMARD tapering is judged not to be suitable by medical expert assessment e.g. patients with previous difficult-to-treat RA.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 24 months
Secondary endpoints 1
- Year 5
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 20
Prednisolone 5mg Soluble Tablets
PRD10020964 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 9.1 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- PL 20117/0373
- MA holder
- MORNINGSIDE HEALTHCARE LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Jyseleca 200 mg film-coated tablets
PRD11572414 · Product
- Active substance
- Filgotinib
- Substance synonyms
- G-146034
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 364 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA45 — -
- Marketing authorisation
- EU/1/20/1480/003
- MA holder
- ALFASIGMA S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 162 mg solution for injection in pre-filled syringe.
PRD1576593 · Product
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 23.14 mg milligram(s)
- Max total dose
- 42.12 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/007
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Olumiant 4 mg film-coated tablets
PRD4760224 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7.28 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA37 — -
- Marketing authorisation
- EU/1/16/1170/009
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1034223 · ATC
- Active substance
- Methotrexate Sodium
- Substance synonyms
- SODIUM METHOTREXATE, MTX SODIUM
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 6.5 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX03 — METHOTREXATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP688656 · ATC
- Active substance
- Certolizumab Pegol
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 14.29 mg milligram(s)
- Max total dose
- 24 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB05 — CERTOLIZUMAB PEGOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129749391 · ATC
- Active substance
- Sarilumab
- Substance synonyms
- SAR153191
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 14.3 mg milligram(s)
- Max total dose
- 24 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC14 — SARILUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP106366361 · ATC
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 12.5 mg milligram(s)
- Max total dose
- 21 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — INFLIXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP138875 · ATC
- Active substance
- Leflunomide
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 36.4 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AK01 — LEFLUNOMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 250 mg powder for concentrate for solution for infusion
PRD2316712 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 35.71 mg milligram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
XELJANZ 5 mg film-coated tablets
PRD4862227 · Product
- Active substance
- Tofacitinib
- Substance synonyms
- CP-609,550, TASOCITINIB
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 18.2 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AF01 — -
- Marketing authorisation
- EU/1/17/1178/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RINVOQ 15 mg prolonged-release tablets
PRD11979189 · Product
- Active substance
- Upadacitinib
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 27.3 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AF03 — -
- Marketing authorisation
- PLGB 41042/0042
- MA holder
- ABBVIE LTD (UK)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP134762 · ATC
- Active substance
- Hydroxychloroquine Sulfate
- Substance synonyms
- 2-[4-[(7-CHLOROQUINOLIN-4-YL)AMINO]PENTYL-ETHYL-AMINO]ETHANOL, SULFURIC ACID, HYDROXYCHLOROQUINE SULPHATE
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 728 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- P01BA02 — HYDROXYCHLOROQUINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10339494 · ATC
- Active substance
- Methotrexate Sodium
- Substance synonyms
- SODIUM METHOTREXATE, MTX SODIUM
- Route of administration
- ORAL
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 6.5 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA01 — METHOTREXATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154620 · Product
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 28.57 mg milligram(s)
- Max total dose
- 48 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP172034 · ATC
- Active substance
- Adalimumab
- Substance synonyms
- ABP 501, BI 695501, MSB11022
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.86 mg milligram(s)
- Max total dose
- 4.8 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — ADALIMUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2316715 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 17.9 mg milligram(s)
- Max total dose
- 32.5 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/006
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP25026557 · ATC
- Active substance
- Golimumab
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 1.67 mg milligram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB06 — GOLIMUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP185437 · ATC
- Active substance
- Etanercept
- Substance synonyms
- CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 7.14 mg milligram(s)
- Max total dose
- 13 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB01 — ETANERCEPT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP130065 · ATC
- Active substance
- Sulfasalazine
- Substance synonyms
- SULPHASALAZINE, SALICYLAZOSULFAPYRIDINE, SASP
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 5460 g gram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC01 — SULFASALAZINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aalborg University Hospital
- Sponsor organisation
- Aalborg University Hospital
- Address
- Reberbansgade 15
- City
- Aalborg
- Postcode
- 9000
- Country
- Denmark
Scientific contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Department of Rheumatology
Public contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Department of Rheumatology
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aalborg University Hospital ORG-100022335
|
Aalborg, Denmark | On site monitoring |
Aalborg University Hospital
- Sponsor organisation
- Aalborg University Hospital
- Address
- Hobrovej 18-22
- City
- Aalborg
- Postcode
- 9000
- Country
- Denmark
Scientific contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Department of Rheumatology
Public contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Department of Rheumatology
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aalborg University Hospital ORG-100022335
|
Aalborg, Denmark | On site monitoring |
Sponsor responsibilities
- Article 77 compliance
- Aalborg University Hospital
- Contact point sponsor
- Aalborg University Hospital
- Article 77 implementation
- Aalborg University Hospital
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 180 | 2 |
| 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 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol_OASEstudy_v1_5 | 1.5 |
| Protocol (for publication) | Protocol_OASEstudy_v1_5_track_changes | 1.5 |
| Recruitment arrangements (for publication) | OASEstudy__Recruitment_procedure_v2 | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin _ Videnskabsetik | 1 |
| Subject information and informed consent form (for publication) | OASEstudy_pt_info_v1_4 | 1.4 |
| Subject information and informed consent form (for publication) | OASEstudy_pt_info_v1_4_track_changes | 1.4 |
| Subject information and informed consent form (for publication) | OASEstudy_samtykke_v1_1 | 1.1 |
| Subject information and informed consent form (for publication) | OASEstudy_tillg_ret_til_ikke_viden_v1_0 | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Abatacept | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Abatacept | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Adalimumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Baricitinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_CertolizumabPegol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Etanercept | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Filgotinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Golimumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Hydroxychloroquine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Infliximab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Leflunomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_MTX_inj | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_MTX_tabl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Prednisolone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Sarilumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Sulfasalazine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Tocilizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Tocilizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Tofacitinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Upadacitinib | 1 |
| Synopsis of the protocol (for publication) | OASEstudy_protocol_synopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-24 | Denmark | Acceptable 2026-06-01
|
2026-07-06 |