Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

NCT04610476 | Unknown Phase 3

• 1 other identifier: UKER-ATTRACTOR -01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for this study is to investigate whether in psoriatic arthritis (PsA) patients in stable remission a reduction or complete discontinuation of immunosuppressive therapy can be achieved in a treat-to-target approach while maintaining in remission. Due to the lack of reliable data that answers the question of how to safely reduce medication in which patients, this study will test a pragmatic treatment algorithm that can be applied in clinical practice and that offers a gradual reduction with escape strategies in order to facilitate the maintenance of remission.

Conditions

Psoriatic Arthritis; Withdrawal; Reduction

Outcome Measures

Primary Outcomes (1)

• Presence of MDA (minimal disease activity) 12 months after baseline.

  The MDA status comprises the assessment of different domains of PsA, consisting of the following individual components: * swollen and tender joint count * tender entheseal point count * skin involvement (PASI)patient self-assessment of pain (VAS) * global disease activity status * subject's self-assessment of functional ability using Stanford Health Assessment Questionnaire disability index, (HAQ-DI) MDA is defined as the presence of 5 of the following 7 criteria: 1. tender joint count ≤1 2. swollen joint count ≤1 3. tender entheseal point count ≤1 (means: remission) 4. PASI ≤1 OR body surface area (BSA) ≤3% 5. patient pain VAS ≤15 6. patient global activity VAS ≤20 7. HAQ-DI ≤0.5

  12 months

Secondary Outcomes (28)

• Key secondary endpoint: PASDAS (Psoriatic Arthritis Disease Activity Score)

  12 months

• Key secondary endpoint: DAPSA (Disease Activity in PSoriatic Arthritis)

  12 months

• Key secondary endpoint: CPDAI (Composite Psoriatic Disease Activity Index)

  12 months

• Number of swollen and tender joints

  12 months

• Number of tender entheseal points: SPARCC (Spondyloarthritis Consortium of Canada)

  12 months

Study Arms (2)

Control group

NO INTERVENTION

Individual previous stable glucocorticoid/DMARD therapy is continued

Reduction group

EXPERIMENTAL

Individual previous stable dosage of glucocorticoids/DMARDs will be stepwise reduced according to a predefined algorithm

Drug: Prednisolone; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Methotrexate; Drug: Tofacitinib; Drug: Apremilast; Drug: Etanercept; Drug: Adalimumab; Drug: Infliximab; Drug: Certolizumab pegol; Drug: Golimumab; Drug: Abatacept; Drug: Secukinumab; Drug: Ixekizumab; Drug: Ustekinumab

Interventions

Prednisolone DRUG

Prednisolone oral 1-5 mg/day

Also known as: Prednisolone generic drugs

Reduction group

Sulfasalazine DRUG

Sulfasalazine oral 2 x 1000 mg/day

Also known as: Azulfidine

Reduction group

Leflunomide DRUG

Leflunomide oral 20 mg/day

Also known as: Arava

Reduction group

Methotrexate DRUG

Methotrexate oral \> 10 - 30 mg/ week/ 10 mg/week/ 7.5 mg/week; s.c. 15 (7.5 -25) mg/week

Also known as: Lantarel, Metex

Reduction group

Tofacitinib DRUG

Tofacitinib oral 2 x 5 mg/day/ 1 x 5 mg/day/11 mg/day

Also known as: Xeljanz

Reduction group

Apremilast DRUG

Apremilast oral 2 x 30 mg/day/1 x 30 mg/day

Also known as: Otezla

Reduction group

Etanercept DRUG

Etanercept s.c. 2 x 25 mg /week OR 1 x 50 mg/week

Also known as: Enbrel, Erelzi, Benepali

Reduction group

Adalimumab DRUG

Adalimumab s.c. 40 mg every 2 weeks

Also known as: Humira, Amgevita, Imraldi, Hyrimoz

Reduction group

Infliximab DRUG

Infliximab i.v. 5 mg/kg BW every 8 weeks

Also known as: Remicade, Zessly, Inflectra

Reduction group

Certolizumab pegol DRUG

Certolizumab pegol s.c. 1x 200 mg every 2 weeks/1x400 mg every 4 weeks

Also known as: Cimzia

Reduction group

Golimumab DRUG

Golimumab s.c. 1x 50 mg every 4 weeks

Also known as: Simponi

Reduction group

Abatacept DRUG

Abatacept s.c. 1x125 mg/week OR Abatacept i.v. 500-1000mg (adapted to BW) every 4 weeks

Also known as: Orencia

Reduction group

Secukinumab DRUG

Secukinumab s.c.1x 150 mg OR 1x 300 mg every 4 weeks

Also known as: Cosentyx

Reduction group

Ixekizumab DRUG

Ixekizumab s.c. 1x 80 mg every 4 weeks

Also known as: Taltz

Reduction group

Ustekinumab DRUG

Ustekinumab s.c. Maintenance dose 1x45 mg every 12 weeks

Also known as: Stelara

Reduction group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from the subject
• Understanding of study procedures and willingness to abide by all procedures during the course of the study.
• Adult subject; age range 18-≤75 years
• Male or female subject
• Diagnosis of PsA according to CASPAR criteria
• Disease status "MDA" for at least 6 months
• Subject should have been treated without alterations of therapy (fixed dose and drug) for at least 6 months with one or more of the following drugs:
• i. csDMARD Leflunomid (e.g. Arava), Sulfasalazin (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) AND/OR ii. bDMARD/tsDMARD: Etanercept (e.g. Enbrel, Erelzi, Benepali), Adalimumab (e.g. Humira, Amgevita, Imraldi, Hyrimoz), Infliximab (e.g. Remicade, Zessly, Inflectra), Golimumab (Simponi), Certolizumab (Cimzia), Abatacept (Orencia), Apremilast (Otezla), Ustekinumab (Stelara), Secukinumab (Cosentyx), Ixekizumab (Taltz), Tofacitinib (Xeljanz) AND/OR (c) glucocorticoids (≤5mg prednisolone equivalent).
• Women of childbearing potential must be using a highly effective method of birth control.
• Male subjects using an adequate contraceptive method at the investigator's discretion.

You may not qualify if:

• Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener
• Concomitant florid (not sufficiently adjusted under treatment) autoimmune disease such as autoimmune hepatitis or Hashimoto's disease
• Use of any inadmissible medication (e.g. current treatment with DMARDs other than mentioned above or drugs under development)
• Malignant disease currently under oncological treatment or history of a recent malignancy with moderate or high risk of relapse within 5 years prior to Screening
• Existence of another disease including the presence of laboratory abnormalities which, at the discretion of the investigator, would result in a disproportionate risk to the patient concerned or confounds the ability to interpret data from the study
• Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before Screening
• Nursing mother or pregnant woman as verified by a positive pregnancy test
• Known hypersensitivity to the IMPs or any of their formulation ingredients
• Subject who is imprisoned or is lawfully kept in an Institution
• Employee or direct relative of an employee of the study site or the Sponsor
• Participation in an interventional clinical study with an IMP within the last 4 weeks before Screening
• Previous participation in this clinical study
• Planned extended stay outside the region which prevents compliance with the visit schedule

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Prednisolone; Sulfasalazine; Leflunomide; Methotrexate; tofacitinib; apremilast; Etanercept; Adalimumab; Infliximab; Certolizumab Pegol; golimumab; Abatacept; secukinumab; ixekizumab; Ustekinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoconjugates

Central Study Contacts

David Simon, MD

CONTACT

+4991318532093; david.simon@uk-erlangen.de

Arnd Kleyer, MD

CONTACT

+4991318532093; arnd.kleyer@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 30, 2020
• Study Start: October 19, 2020
• Primary Completion: October 19, 2024
• Study Completion: October 19, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)