A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— SPIRIT-P2  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349295
• Other study ID #: 14310
• Secondary ID: I1F-MC-RHBE2011-
• Status: Completed
• Phase: Phase 3
• Start date: December 31, 2014
• Est. completion date: June 26, 2019

Study information

• Verified date: September 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: June 26, 2019
• Est. primary completion date: September 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

• Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

• Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

• Men must agree to use a reliable method of birth control or remain abstinent during the study

• Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

• Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

• Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.

Exclusion Criteria:

• Current use of biologic agents for treatment of Ps or PsA

• Inadequate response to greater than 2 biologic DMARDs

• Current use of more than one cDMARDs

• Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA

• Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy

• Serious disorder or illness other than psoriatic arthritis

• Serious infection within the last 3 months

• Breastfeeding or nursing (lactating) women

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Placebo
Administered SC
• Ixekizumab 80 mg Q4W
Administered SC
• Ixekizumab 80 mg Q2W
Administered SC

Locations

Country	Name	City	State
Australia	Emeritus Research	Camberwell	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Coast Joint Care	Maroochydore	Queensland
Czechia	CCBR Czech Prague, s.r.o.	Praha
Czechia	MEDICAL PLUS, s.r.o.	Uherske Hradiste
Czechia	PV-MEDICAL s.r.o. Revmatologicka ambulance	Zlin
France	Hôpital Trousseau, CHRU de Tours	Chambray-lès-Tours
France	CHU de Montpellier-Hopital Arnaud de Villeneuve	Montpellier Cedex 5
France	Chru De Nantes Hotel-Dieu	Nantes Cedex 1
France	Hopital Cochin	Paris CEDEX 14
France	Hopital Purpan	Toulouse
France	CHU Brabois	Vandoeuvre Les Nancy
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum	Dresden	Sachsen
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	HRF Hamburger Rheuma Forschungszentrum	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Rheumazentrum Ruhrgebiet	Herne	Nordrhein-Westfalen
Germany	Universität Leipzig - Universitätsklinikum	Leipzig	Sachsen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Italy	Istituto Ortopedico Gaetano Pini	Milano
Italy	Azienda Ospedaliera - Universitaria Pisana	Pisa
Poland	Malopolskie Centrum Medyczne S.C.	Krakow
Poland	Medica pro Familia Sp z o.o. S.K.A	Krakow
Poland	AI Centrum Medyczne	Poznan
Poland	Medica pro Familia Sp z o.o. S.K.A	Warszawa
Poland	Rheuma Medicus Zaklad Opieki Zdrowotnej	Warszawa
Spain	Hospital De Basurto	Bilbao	Vizcaya
Spain	Hospital De Fuenlabrada	Fuenlabrada	Madrid
Spain	Complexo Hospitalario Universitario A Coruña, CHUAC	La Coruña
Spain	Hospital Regional Universitario de Málaga	Malaga
Spain	Centro de Salud Mental Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario Marques De Valdecilla	Santander	Cantabria
Spain	Hospital Infanta Luisa	Sevilla	Andalucia
Spain	Hospital Universitario Nuestra Señora de Valme	Sevilla
Taiwan	Chang Gung Memorial Hospital - Kaohsiung	Kaohsiung City (r.o.c)
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung City
Taiwan	Chi-Mei Hospital, Liouying	Tainan City	Yongkang Dist
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan City
United Kingdom	Basildon and Thurrock University Hospital	Basildon	Essex
United Kingdom	King George Hospital	Goodmayes	Essex
United Kingdom	Princess Alexandra Hospital	Harlow	Essex
United Kingdom	Chapel Allerton Hospital	Leeds	West Yorkshire
United Kingdom	Whipps Cross University Hospital	London	Surrey
United Kingdom	New Cross Hospital	Wolverhampton	West Midlands
United States	The Center for Rheumatology	Albany	New York
United States	Albuquerque Rehabilitation & Rheumatology, PC	Albuquerque	New Mexico
United States	Austin Regional Clinic	Austin	Texas
United States	Austin Rheumatology Research PA	Austin	Texas
United States	Johns Hopkins Arthritis Center	Baltimore	Maryland
United States	Rheumatology Associates PC	Birmingham	Alabama
United States	Rheumatology Associates of South Florida	Boca Raton	Florida
United States	Tufts Medical Center	Boston	Massachusetts
United States	Weill Cornell Medical College	Brooklyn	New York
United States	Physicians Clinic of Iowa	Cedar Rapids	Iowa
United States	Arthritis and Osteoporosis Consultants of the Carolinas	Charlotte	North Carolina
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	New Jersey Physicians	Clifton	New Jersey
United States	Klein and Associates MD, PA	Cumberland	Maryland
United States	Arthritis Care & Diagnostic Center P.A.	Dallas	Texas
United States	STAT Research	Dayton	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Rheumatology and Immunotherapy Center	Franklin	Wisconsin
United States	Arizona Arthritis & Rheumatology Research	Glendale	Arizona
United States	Klein and Associates MD, PA	Hagerstown	Maryland
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Accurate Clinical Research	Houston	Texas
United States	Houston Institute for Clinical Research	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Diagnostic Rheumatology and Research	Indianapolis	Indiana
United States	Glacier View Research Institute	Kalispell	Montana
United States	Kadlec Clinic Rheumatology	Kennewick	Washington
United States	University of California - San Diego	La Jolla	California
United States	Purushotham & Akther Kotha MD Inc	La Mesa	California
United States	Beals Institute PC	Lansing	Michigan
United States	Accurate Clinical Research	League City	Texas
United States	Bluegrass Community Research. Inc	Lexington	Kentucky
United States	PMA Medical Specialists, LLC	Limerick	Pennsylvania
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	Arthritis & Osteoporosis Associates LLP	Lubbock	Texas
United States	Methodist Healthcare	Memphis	Tennessee
United States	Ramesh C. Gupta MD	Memphis	Tennessee
United States	Arizona Arthritis & Rheumatology Research, PLLC	Mesa	Arizona
United States	Jeffrey Alper MD Research	Naples	Florida
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Arthritis & Osteoporosis Treatment Center, PA	Orange Park	Florida
United States	Stanford University Hospital	Palo Alto	California
United States	Arizona Arthritis & Rheumatology Research	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Allergy Asthma Immunology of Rochester, AAIR Research Ctr	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	East Bay Rheumatology Medical Group	San Leandro	California
United States	Swedish Medical Center	Seattle	Washington
United States	Rheumatology Associates of Long Island	Smithtown	New York
United States	Arthritis Northwest PLLC	Spokane	Washington
United States	Atlantic Coastal Research	Toms River	New Jersey
United States	North MS Medical Clinics, Inc.	Tupelo	Mississippi
United States	Office: Dr Robin K Dore	Tustin	California
United States	Arthritis, Rheumatic & Back Disease Associates	Voorhees	New Jersey
United States	Heartland Research Associates	Wichita	Kansas
United States	Clinical Research Center of Reading, LLC	Wyomissing	Pennsylvania
United States	Pennsylvania Regional Center for Arthritis & Osteoarthritis	Wyomissing	Pennsylvania
United States	Florida Medical Clinic PA	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  France,  Germany,  Italy,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)	ACR20 response is defined as a greater than or equal to (=) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).	Week 24
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.	Baseline, Week 24
Secondary	Percentage of Participants Achieving ACR20	ACR20 response is defined as a =20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.	Week 12
Secondary	Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)	ACR50 response is defined as a =50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.	Week 24
Secondary	Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)	ACR70 response is defined as a =70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.	Week 24
Secondary	Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75	The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.	Week 12
Secondary	Percentage of Patients Achieving Minimal Disease Activity (MDA)	It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC =1, 2. SJC =1, 3. PASI total score =1 or BSA =3, 4. patient pain VAS score of =15, 5. patient global VAS score of =20, 6. HAQ-DI score =0.5, 7. tender entheseal points (6 entheseal points) =1.	Week 24
Secondary	Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)	The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.	Week 24
Secondary	Change From Baseline in Itch Numeric Rating Scale (NRS)	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 12
Secondary	Change From Baseline in Tender Joint Count (TJC)	TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in Swollen Joint Count (SJC)	SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)	The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in Patients Global Assessment of Disease Activity VAS	The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in Physicians Global Assessment of Disease Activity VAS	The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in C-Reactive Protein (CRP)	C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)	The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score	The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score	The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.	Baseline, Week 24
Secondary	Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)	Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.	Week 24
Secondary	Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab	The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.	All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Secondary	Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab	The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).	All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Secondary	Percentage of Participants Achieving ACR 20	ACR20 response is defined as a =20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.	Week 52 and Week 156
Secondary	Percentage of Participants Achieving ACR 50	ACR50 response is defined as a =50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.	Week 52 and Week 156
Secondary	Percentage of Participants Achieving ACR 70	ACR70 response is defined as a =70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.	Week 52 and Week 156

External Links

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