A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175877
• Other study ID #: C87028
• Secondary ID: 2005-001350-24
• Status: Completed
• Phase: Phase 3
• Start date: June 2005
• Est. completion date: February 2012

Study information

• Verified date: March 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 857
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the entire Week 52 assessment of C87027 [NCT00152386] trial.

Exclusion Criteria:

• A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)

• A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis

• Any concomitant biological therapy

• Any experimental therapy, within or outside a clinical trial

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Signs and Symptoms

Intervention

Biological:
• Certolizumab Pegol
Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Locations

Country	Name	City	State
Argentina	12	Buenos Aires
Argentina	1	Capital Federal
Argentina	14	Capital Federal
Argentina	9	Capital Federal
Argentina	8	Ciudad Autonoma de Buenos Aire
Argentina	11	Cordoba
Argentina	2	Cordoba
Argentina	13	Quilmes
Argentina	7	Rosario
Argentina	10	San Miguel de Tucuman
Argentina	6	Santa Fe
Australia	18	Malvern
Australia	21	Maroochydore
Australia	23	Perth
Belgium	179	Antwerpen
Belgium	199	Liege
Belgium	177	Merksem
Bulgaria	29	Pleven
Bulgaria	221	Sofia
Bulgaria	28	Sofia
Bulgaria	30	Sofia
Bulgaria	26	Stara Zagora
Canada	35	Hamilton
Canada	36	Kitchener
Canada	43	Newmarket	Ontario
Canada	201	Pointe Claire
Canada	31	Sainte Foy
Canada	32	Toronto	Ontario
Canada	39	Toronto	Ontario
Canada	203	Winnipeg
Chile	190	Santiago de Chile
Chile	49	Santiago de Chile
Chile	44	Valdivia
Croatia	52	Rijeka
Czechia	56	Brno
Czechia	57	Ostrava Trebovice
Czechia	187	Plzen
Czechia	55	Praha
Czechia	61	Praha 2
Czechia	60	Praha 5
Czechia	58	Uherske Hradiste
Czechia	62	Zlin
Estonia	64	Parnu
Estonia	65	Tallinn
Estonia	63	Tartu
Finland	68	Hyvinkaa
France	160	Montpellier Cedex 5
Hungary	71	Budapest
Hungary	73	Budapest
Hungary	75	Bupadest
Hungary	191	Debrecen
Hungary	76	Miskolc
Hungary	74	Szolnok
Israel	79	Afula
Israel	82	Ashkelon
Israel	81	Haifa
Israel	83	Haifa
Israel	78	Ramat Gan
Israel	77	Tel Aviv
Israel	85	Zerifin
Latvia	86	Riga
Latvia	88	Riga
Lithuania	92	Alytus
Lithuania	89	Kaunas
Lithuania	91	Klaipeda
Lithuania	93	Panevezys
Lithuania	90	Siauliai
Lithuania	94	Vilnius
Mexico	95	Mexicalli
Mexico	96	Monterrey
New Zealand	103	Auckland
New Zealand	101	Christchurch
New Zealand	100	South Canterbury
New Zealand	192	Tauranga
Russian Federation	107	Moscow
Russian Federation	113	Moscow
Russian Federation	222	Moscow
Russian Federation	223	Moscow
Russian Federation	224	Moscow
Russian Federation	109	St. Petersburg
Russian Federation	111	St. Petersburg
Russian Federation	112	St. Petersburg
Russian Federation	193	St. Petersburg
Russian Federation	110	Yaroslavl
Serbia	117	Belgrade
Serbia	118	Belgrade
Serbia	114	Niska Banja
Serbia	115	Novi Sad
Slovakia	119	Bratislava
Slovakia	121	Kosice
Slovakia	120	Piestany
Slovakia	122	Piestany
Ukraine	210	Dnepropetrovsk
Ukraine	209	Donetsk
Ukraine	216	Donetsk
Ukraine	213	Ivano-Frankivsk
Ukraine	211	Kiev
Ukraine	212	Kiev
Ukraine	215	Kiev
Ukraine	220	Kiev
Ukraine	208	Symferopyl
Ukraine	214	Zaporozhye
United States	137	Austin	Texas
United States	139	Charleston	South Carolina
United States	135	Charlotte	North Carolina
United States	147	Cleveland	Ohio
United States	157	Coeur d'Alene	Idaho
United States	153	Danbury	Connecticut
United States	158	Dayton	Ohio
United States	152	Huntsville	Alabama
United States	156	Lincoln	Nebraska
United States	133	Ocala	Florida
United States	140	Orlando	Florida
United States	150	Orlando	Florida
United States	151	Saint Louis	Missouri
United States	143	San Antonio	Texas
United States	148	San Diego	California
United States	145	Sarasota	Florida
United States	155	Springfield	Illinois
United States	136	Tampa	Florida
United States	134	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  Estonia,  Finland,  France,  Hungary,  Israel,  Latvia,  Lithuania,  Mexico,  New Zealand,  Russian Federation,  Serbia,  Slovakia,  Ukraine, 

References & Publications (4)

Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level — View Citation

Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewé R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results f — View Citation

Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients with Rheumatoid Arthritis. Clin Transl Sci. 2020 Feb 26. doi: 10.1111/cts.12760. [Epub ahead of print] — View Citation

van der Heijde D, Keystone EC, Curtis JR, Landewé RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years	An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.; First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.	From first dose of CZP to the end of the open-label study (approximately 7 years)
Primary	Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years	A SAE is any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalisation or prolongation of existing hospitalisation; Results in persistent or significant disability/incapacity, or; Is a congenital anomaly or birth defect; Is as infection that requires treatment parenteral antibiotics; Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above; First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.	From first dose of CZP to the end of the open-label study (approximately 7 years)
Primary	Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study	An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.	From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48	The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 48 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96	The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144	The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 144 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192	The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 192 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240	The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 240 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal	The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48	The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 48 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96	The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144	The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 144 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192	The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 192 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240	The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 240 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal	The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48	The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 48 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96	The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144	The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 144 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192	The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 192 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240	The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Week 240 of the open-label study
Secondary	Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal	The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)	The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.	From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary	Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score	The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness	Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])	DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit	Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score	The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary	Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score	The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).	From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

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