A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— BE VITAL  

Official title:

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04009499
• Other study ID #: PA0012
• Secondary ID: 2018-004725-86
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 13, 2019
• Est. completion date: May 25, 2026

Study information

• Verified date: May 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1131
• Est. completion date: May 25, 2026
• Est. primary completion date: May 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study

• Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria

• Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Exclusion Criteria:

• Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)

• Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator

• Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Locations

Country	Name	City	State
Australia	Pa0012 30005	Camberwell
Australia	Pa0012 30002	Clayton
Australia	Pa0012 30008	Hobart
Australia	Pa0012 30003	Maroochydore
Australia	Pa0012 30007	Victoria Park
Australia	Pa0012 30006	Woodville South
Belgium	Pa0012 40003	Genk
Belgium	Pa0012 40002	Leuven
Belgium	Pa0012 40059	Mons
Canada	Pa0012 50041	Quebec
Canada	Pa0012 50042	Rimouski
Canada	Pa0012 50043	Sydney
Canada	Pa0012 50044	Trois-rivieres
Czechia	Pa0012 40061	Brno
Czechia	Pa0012 40065	Brno
Czechia	Pa0012 40062	Ostrava
Czechia	Pa0012 40009	Pardubice
Czechia	Pa0012 40013	Praha 11
Czechia	Pa0012 40066	Praha 2
Czechia	Pa0012 40015	Praha 3
Czechia	Pa0012 40014	Praha 4
Czechia	Pa0012 40063	Praha 5
Czechia	Pa0012 40010	Uherske Hradiste
Czechia	Pa0012 40012	Zlin
France	Pa0012 40068	Chambray Les Tours
France	Pa0012 40019	Paris
Germany	Pa0012 40074	Bad Doberan
Germany	Pa0012 40025	Berlin
Germany	Pa0012 40076	Cottbus
Germany	Pa0012 40023	Erlangen
Germany	Pa0012 40117	Frankfurt
Germany	Pa0012 40029	Hamburg
Germany	Pa0012 40071	Hamburg
Germany	Pa0012 40027	Herne
Germany	Pa0012 40078	Leipzig
Germany	Pa0012 40026	Ratingen
Hungary	Pa0012 40081	Budapest
Hungary	Pa0012 40083	Budapest
Hungary	Pa0012 40032	Debrecen
Hungary	Pa0012 40030	Eger
Hungary	Pa0012 40082	Kistarcsa
Hungary	Pa0012 40033	Székesfehérvár
Hungary	Pa0012 40079	Szentes
Italy	Pa0012 40084	Catania
Italy	Pa0012 40087	Milano
Italy	Pa0012 40086	Reggio Emilia
Japan	Pa0012 20035	Bunkyo-ku
Japan	Pa0012 20030	Chuo-ku
Japan	Pa0012 20043	Itabashi-ku
Japan	Pa0012 20036	Kawachinagano
Japan	Pa0012 20045	Kita-gun
Japan	Pa0012 20049	Kitakyushu
Japan	Pa0012 20044	Minato-ku
Japan	Pa0012 20033	Nagoya
Japan	Pa0012 20041	Osaka
Japan	Pa0012 20046	Osaka
Japan	Pa0012 20048	Saitama
Japan	Pa0012 20031	Sapporo
Japan	Pa0012 20042	Sasebo
Japan	Pa0012 20032	Suita
Poland	Pa0012 40093	Bialystok
Poland	Pa0012 40119	Bydgoszcz
Poland	Pa0012 40038	Elblag
Poland	Pa0012 40088	Elblag
Poland	Pa0012 40096	Gdynia
Poland	Pa0012 40042	Krakow
Poland	Pa0012 40092	Krakow
Poland	Pa0012 40037	Lublin
Poland	Pa0012 40091	Nowa Sol
Poland	Pa0012 40044	Poznan
Poland	Pa0012 40090	Poznan
Poland	Pa0012 40118	Torun
Poland	Pa0012 40041	Warszawa
Poland	Pa0012 40094	Warszawa
Poland	Pa0012 40097	Warszawa
Poland	Pa0012 40098	Warszawa
Poland	Pa0012 40039	Wroclaw
Poland	Pa0012 40043	Wroclaw
Poland	Pa0012 40095	Wroclaw
Russian Federation	Pa0012 20002	Moscow
Russian Federation	Pa0012 20005	Moscow
Russian Federation	Pa0012 20010	Moscow
Russian Federation	Pa0012 20017	Moscow
Russian Federation	Pa0012 20013	Petrozavodsk
Russian Federation	Pa0012 20012	Ryazan
Russian Federation	Pa0012 20016	Ryazan
Russian Federation	Pa0012 20004	Saint Petersburg
Russian Federation	Pa0012 20001	Saint-petersburg
Russian Federation	Pa0012 20003	Saint-petersburg
Russian Federation	Pa0012 20009	Saint-petersburg
Russian Federation	Pa0012 20083	Saint-petersburg
Russian Federation	Pa0012 20007	Saratov
Russian Federation	Pa0012 20014	Ulyanovsk
Russian Federation	Pa0012 20006	Vladimir
Russian Federation	Pa0012 20008	Yaroslavl
Russian Federation	Pa0012 20015	Yaroslavl
Spain	Pa0012 40045	A Coruna
Spain	Pa0012 40105	Cordoba
Spain	Pa0012 40102	Málaga
Spain	Pa0012 40101	Sabadell
Spain	Pa0012 40104	Santiago de Compostela
Spain	Pa0012 40049	Sevilla
Spain	Pa0012 40106	Sevilla
Spain	Pa0012 40099	Vigo
United Kingdom	Pa0012 40109	Oxford
United Kingdom	Pa0012 40116	Peterborough
United Kingdom	Pa0012 40107	Wolverhampton
United States	Pa0012 50029	Albuquerque	New Mexico
United States	Pa0012 50039	Atlanta	Georgia
United States	Pa0012 50002	Austin	Texas
United States	Pa0012 50023	Baton Rouge	Louisiana
United States	Pa0012 50050	Beckley	West Virginia
United States	Pa0012 50024	Boise	Idaho
United States	Pa0012 50047	Boston	Massachusetts
United States	Pa0012 50010	Brooklyn	New York
United States	Pa0012 50125	Charlotte	North Carolina
United States	Pa0012 50049	Corpus Christi	Texas
United States	Pa0012 50020	Duncansville	Pennsylvania
United States	Pa0012 50005	Freehold	New Jersey
United States	Pa0012 50015	Hagerstown	Maryland
United States	Pa0012 50001	Jackson	Tennessee
United States	Pa0012 50008	Johnston	Rhode Island
United States	Pa0012 50019	Lansing	Michigan
United States	Pa0012 50028	Lexington	Kentucky
United States	Pa0012 50012	Memphis	Tennessee
United States	Pa0012 50036	Mesquite	Texas
United States	Pa0012 50011	New York	New York
United States	Pa0012 50007	Orangeburg	South Carolina
United States	Pa0012 50033	Palm Harbor	Florida
United States	Pa0012 50017	Phoenix	Arizona
United States	Pa0012 50034	Rochester	New York
United States	Pa0012 50016	Saint Louis	Missouri
United States	Pa0012 50031	Salisbury	North Carolina
United States	Pa0012 50035	San Diego	California
United States	Pa0012 50037	Tampa	Florida
United States	Pa0012 50040	Vandalia	Ohio
United States	Pa0012 50009	Waco	Texas
United States	Pa0012 50026	Wheaton	Maryland
United States	Pa0012 50006	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) during the study	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Primary	Incidence of treatment-emergent serious adverse events (SAEs) during the study	A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalization or prolongation of existing hospitalization; Is a congenital anomaly or birth defect; Is an infection that requires treatment parenteral antibiotics; Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above	From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary	TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary	American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011	The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011	The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011	The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011	The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011	The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011	The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011	The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011	The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011	The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011	The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.; The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.; The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011	The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.; The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.; The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011	The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.; The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.; The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011	The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.; The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.; The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011	The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.; The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.; The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011	The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.; The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.; The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011	A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA =2 at the Baseline of PA0010 or PA0011.; An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011	A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA =2 at the Baseline of PA0010 or PA0011.; An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011	A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA =2 at the Baseline of PA0010 or PA0011.; An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011	Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011	Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011	Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011	Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011	Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011	Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.	Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary	Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011	Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary	Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011	Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary	Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011	Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.	Baseline of PA0010 or PA0011, Week 140 in PA0012