Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis

NCT ID: NCT05291819

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2027-12-31

Brief Summary

The main objective is to assess if a treat-to-target strategy implementing structured imaging assessments leads to better patient outcome in terms of sustained remission compared to a conventional treat-to-target strategy in psoriatic arthritis.

Main inclusion criteria are: >18 years of age, Clinical diagnosis of psoriatic arthritis (PsA), Fulfillment of ClASsification of Psoriatic Arthritis (CASPAR) criteria, Indication for treatment with disease modifying anti-rheumatic drugs according to treating physician

Primary endpoint: Sustained remission, defined as Very Low Disease Activity (VLDA) at 16, 20 and 24 months

Secondary endpoints: Individual and composite disease activity measures and remission criteria, inflammation assessed by ultrasound, health related quality of life and adverse events.

Study design: A two-arm, parallel-group, single-blind, treatment strategy study where patients are randomized 1:1 to a conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity or an imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. Duration of follow-up is 24 months.

All patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the sole target in the conventional arm, is all of: Disease Activity index in Psoriatic Arthritis (DAPSA) remission (≤3), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%

Intervention: A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information. Specifically, this means that these additional measures will be added to conventional treat to target:

• If evidence of enthesitis or axial inflammation on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm
• If evidence of ongoing inflammation (power Doppler>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target

Detailed Description

This project addresses the challenges associated with psoriatic arthritis (PsA), which is a diverse disease which is difficult to assess clinically. Ultrasound and magnetic resonance imaging (MRI) visualize inflammation that is not apparent on clinical examination, but whether treating patients according to these findings improves outcomes is unknown.

The main objective is to assess if a treat-to-target strategy implementing structured imaging assessments leads to better patient outcome in terms of sustained remission compared to a conventional treat-to-target strategy in psoriatic arthritis.

Primary endpoint: Sustained remission, defined as Very Low Disease Activity (VLDA) at all of the 16, 20 and 24 month visits.

Secondary endpoints include Individual and composite disease activity measures and remission criteria, inflammation assessed by ultrasound, health related quality of life and adverse events.

Study design: A two-arm, parallel-group, single-blind, treatment strategy study where patients are randomized 1:1 to a conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity or an imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. Duration of follow-up is 24 months.

All patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the sole target in the conventional arm, is all of: Disease Activity index in Psoriatic Arthritis (DAPSA) remission (≤3), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%

Intervention: A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information. Specifically, this means that these additional measures will be added to conventional treat to target:

If evidence of enthesitis or axial inflammation on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm If evidence of ongoing inflammation (power Doppler>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional treat-to-target

Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity

Group Type: OTHER

Conventional treat-to-target

Intervention Type: OTHER

Patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the target in the conventional arm, is all of: Disease Activity index in PSoriatic Arthritis (DAPSA) remission (≤4), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%

Imaging informed treat-to-target

Imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity.

Group Type: EXPERIMENTAL

Imaging informed treat-to-target

Intervention Type: OTHER

A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information

Specifically, this means that these additional measures will be added to conventional treat to target:

• If evidence of enthesitis (power Doppler>0 in enthesis) or axial inflammation (SPARCC score ≥ 2* in SI-joint or SPARCC score ≥ 5 in presence of clinical symptoms of axial disease) on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm
• If evidence of ongoing inflammation (power Doppler>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target

Interventions

Imaging informed treat-to-target

A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information

Specifically, this means that these additional measures will be added to conventional treat to target:

• If evidence of enthesitis (power Doppler>0 in enthesis) or axial inflammation (SPARCC score ≥ 2* in SI-joint or SPARCC score ≥ 5 in presence of clinical symptoms of axial disease) on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm
• If evidence of ongoing inflammation (power Doppler>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target

Intervention Type: OTHER

Conventional treat-to-target

Patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the target in the conventional arm, is all of: Disease Activity index in PSoriatic Arthritis (DAPSA) remission (≤4), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adult (>18 years of age)

2. Clinical diagnosis of PsA

3. Indication for treatment with DMARDs according to treating physician (including having attempted ≥2 non-steroidal anti-inflammatory drugs (NSAIDs) for a minimum of 4 weeks in total in predominantly axial and/or entheseal disease)

4. Fulfillment of CASPAR criteria for PsA

Exclusion Criteria

1. Verified arthritis >1 year prior to inclusion

2. Previous DMARD treatment for PsA

3. Systemic glucocorticoid use within the last 3 months

4. Local glucocorticoid injections within the last 4 weeks

5. Major co-morbidities, including but not limited to relevant malignancies, severe diabetes mellitus, severe infections, uncontrolled hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases and cirrhosis.

6. Indications of active or latent tuberculosis (TB) as assessed by chest radiograph and TB interferon gamma release assay (IGRA). Patients with documented adequately treated latent TB can be included.

7. Any other medical condition that according to the treated physician and/or local guidelines makes adherence to treatment protocol impossible

8. Abnormal renal function, defined as serum creatinine >142 µmol/L in female and >168 µmol/L in male, or estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m2

9. Abnormal liver function (defined as Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >1.5 x upper normal limit), active or recent hepatitis

10. Significant anemia, leukopenia and/or thrombocytopenia

11. Inadequate birth control, pregnancy, and/or breastfeeding (current at screening or planned within the duration of the study)

12. Contraindications to magnetic resonance imaging

13. Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible

14. Established or suspected widespread-pain syndrome/fibromyalgia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Siri Lillegraven

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siri Lillegraven, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet

Locations

Department of Rheumatology, Helse Møre og Romsdal HF

Ålesund, , Norway

Site Status: RECRUITING

Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF

Bergen, , Norway

Site Status: RECRUITING

Department of Rheumatology, Drammen Hospital, Vestre Viken HF

Drammen, , Norway

Site Status: RECRUITING

Helse Førde

Førde, , Norway

Site Status: RECRUITING

Haugesunds Sanitetsforening Revmatismesykehus

Haugesund, , Norway

Site Status: RECRUITING

Sørlandet Sykehus

Kristiansand, , Norway

Site Status: RECRUITING

Revmatismesykehuset AS

Lillehammer, , Norway

Site Status: RECRUITING

Helgelandssykehuset, Mo i Rana

Mo i Rana, , Norway

Site Status: RECRUITING

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, , Norway

Site Status: RECRUITING

Martina Hansens Hospital AS

Sandvika, , Norway

Site Status: RECRUITING

University Hospital of Northern Norway

Tromsø, , Norway

Site Status: RECRUITING

Department of Rheumatology, St Olavs Hospital HF

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Siri Lillegraven, MD, MPH, PhD

Role: CONTACT

siri.lillegraven@diakonsyk.no

+4722451500

Even Lillejordet, MD

Role: CONTACT

even.lillejordet@diakonsyk.no

Facility Contacts

Maud-Kristine Aga Ljoså, MD

Role: primary

Bjørg-Tilde Fevang, MD PhD

Role: primary

Ada S. Wierød, MD

Role: primary

Anja Myhre Hjelle, MD, PhD

Role: primary

Mathias M Braaten, MD

Role: primary

Jintana B Andersen, MD PhD

Role: primary

Yi Hu, MD, PhD

Role: primary

Yi.Hu@revmatismesykehuset.no

Inger M Hansen, MD

Role: primary

Even Lillejordet, MD

Role: primary

even.lillejordet@diakonsyk.no

+22451500

Annicken Slagsvold, MD

Role: primary

Gunnstein Bakland, MD, PhD

Role: primary

Agnete Malm Gulati, MD, PhD

Role: primary

Other Identifiers

NOR-SPRINT protocol ver4_1

Identifier Type: -

Identifier Source: org_study_id