Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

NCT04517669 | Completed Results

• 2 other identifiers: A3921332TOPSATI
• Study Type: observational
• Target: 116
• Locations: 8 countries
• Sites: 41

Brief Summary

This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6

  PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.

  At Month 6

Secondary Outcomes (22)

• Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12

  At Month 3 and Month 12

• Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12

  At Month 3, Month 6 and Month 12

• Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12

  At Month 3, Month 6 and Month 12

• Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12

  At Month 3, Month 6 and Month 12

• Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12

  Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12

Eligibility Criteria

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

Study Population

This study will enroll approximately 500 patients from rheumatologists and/or PsA specialist centers in 10 countries (Belgium, Czech Republic, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden, and Switzerland) over an enrollment period of 12 months. The above list of countries are anticipated to participate in this study, however additional countries may be included at a later time. Each patient will have up to 12 months of follow-up for a total study duration of 24 months. Consecutive patients attending a routine clinical visit will be invited to participate if they meet the eligibility criteria for the study and are to start on treatment with tofacitinib for active PsA.

You may qualify if:

• Patients aged ≥ 18 years
• Moderate to severe PsA disease activity diagnosed
• Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
• Patients are treatment naïve to tofacitinib on the date of providing informed consent
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
• Patients on DMARDs must have not had a treatment change in the past 3 months

You may not qualify if:

• Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
• Patient is pregnant or breastfeeding
• Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
• Active treatment for a malignancy
• Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (41)

Algemeen Stedelijk Ziekenhuis

Aalst, 9300, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Nova Reuma Społka Partnerska

Genk, 3600, Belgium

Location

Sygehus Vendsyssel Hospital

Hjørring, Denmark

Location

Turku University Hospital

Turku, Finland

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, 25000, France

Location

Centre Hospitalier Jean Rougier

Cahors, 46000, France

Location

Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69300, France

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Hopital Pasteur

Nice, 6001, France

Location

CHR Orleans

Orléans, 45067, France

Location

Hopital Purpan

Toulouse, 31059, France

Location

CHU Tours - Hôpital Trousseau

Tours, 37044, France

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Soroka University Medical Center

Beersheba, 84001, Israel

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

The Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

Location

Rambam Health Care Center

Haifa, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 246000, Israel

Location

Hadassah Hebrew University Medical Center - Ein Kerem

Jerusalem, 91120, Israel

Location

Galilee Medical Center

Nahariya, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

The Baruch Padeh Medical Center - Poriya

Tiberias, 15208, Israel

Location

Medisch Spectrum Twente, Haaksbergerstraat

Enschede, 7512 KZ, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

C.H. Universitario de Vigo- Hospital Meixoeiro

Vigo, Galicia, 36200, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital de Especialidades de Jerez de la Frontera

Cadiz, 11407, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario San Cecilio

Granada, 18012, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Lund University

Lund, Sweden

Location

Skånes Universitetssjukhus, Malmö

Malmo, Sweden

Location

Karolinska University Hospital, Solna

Stockholm, Sweden

Location

Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten

Umeå, Sweden

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Psoriatic

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov.Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: May 17, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); NL (2); ES (10); FR (8); SE (4); IL (12); DK (1); BE (3)