Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— OPTIMA  

Official title:

A Multicenter, Randomized, Double-Period, Double − Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420927
• Other study ID #: M06-810
• Secondary ID: 2006-004139-31
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2007
• Last updated: April 16, 2012
• Start date: December 2006
• Est. completion date: July 2010

Study information

• Verified date: April 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria : Federal Ministry for Labour, Health, and Social AffairsBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéGermany: Federal Institute for Drugs and Medical DevicesGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyMexico: Federal Commission for Protection Against Health RisksNetherlands: Ministry of Health, Welfare and SportNew Zealand: Health Research CouncilNew Zealand: Ministry of HealthNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).

Description:

This was a 78-week, multicenter, randomized, double-blind, double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early RA. Subjects were randomized to receive adalimumab 40 mg every other week (eow) or placebo subcutaneous injections in combination with orally administered MTX for 26 weeks (Period 1). All subjects in all arms received open-label MTX weekly throughout the study (both Period 1 and Period 2).

At Weeks 22 and 26, subjects were assessed for achievement of low disease activity, defined as a DAS28 score below 3.2. DAS28 is a measure of RA disease activity calculated using the number of tender and swollen joints (out of a total of 28), C-reactive protein level (CRP, a blood marker of inflammation), and the patient's global assessment of disease activity (indicated by marking a 10 cm line between very good and very bad). Subjects who achieved low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were randomized to receive MTX monotherapy (placebo and MTX) or combination therapy (adalimumab and MTX) in a 1:1 ratio for the duration of Period 2 (52 weeks, i.e., to Week 78 of the study). Subjects achieving low disease activity at Week 22 and 26 in the placebo arm (MTX monotherapy) at the end of Period 1 continued to receive MTX monotherapy (and placebo injections in a blinded fashion) for the duration of Period 2. Subjects failing to achieve low disease activity at Week 22 and 26 at the end of Period 1 received open-label combination therapy during Period 2 regardless of treatment assignment in Period 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Subject must be 18 or older and in good health

• Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis

• Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed

• Subject must fulfill at least one of the following three criteria:

• Rheumatoid factor positive

• Greater than 1 joint erosion

• Anti-cyclic citrullinated peptide (CCP) antibody positive.

Exclusion Criteria

• Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy

• Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline

• Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

Drug:
• methotrexate
Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.

Biological:
• placebo
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

Locations

Country	Name	City	State
Argentina	Site Reference ID/Investigator# 3886	Buenos Aires
Argentina	Site Reference ID/Investigator# 3888	Buenos Aires
Argentina	Site Reference ID/Investigator# 6346	Buenos Aires
Argentina	Site Reference ID/Investigator# 3887	Quilmes
Argentina	Site Reference ID/Investigator# 3889	San Miguel de Tucuman
Australia	Site Reference ID/Investigator# 8380	Campsie, Sydney
Australia	Site Reference ID/Investigator# 6954	Clayton
Australia	Site Reference ID/Investigator# 6940	Malvern East
Austria	Site Reference ID/Investigator# 3911	Graz
Austria	Site Reference ID/Investigator# 3915	Graz
Austria	Site Reference ID/Investigator# 3880	Vienna
Austria	Site Reference ID/Investigator# 3885	Vienna
Austria	Site Reference ID/Investigator# 3916	Vienna
Austria	Site Reference ID/Investigator# 7792	Vienna
Belgium	Site Reference ID/Investigator# 3914	Brussels
Belgium	Site Reference ID/Investigator# 3909	Genk
Belgium	Site Reference ID/Investigator# 3881	Gilly
Belgium	Site Reference ID/Investigator# 3376	Liege
Belgium	Site Reference ID/Investigator# 6720	Mechelen
Belgium	Site Reference ID/Investigator# 6718	Sint-Niklaas
Belgium	Site Reference ID/Investigator# 3910	Yvoir
Canada	Site Reference ID/Investigator# 6701	Burlington
Canada	Site Reference ID/Investigator# 6834	Edmonton
Canada	Site Reference ID/Investigator# 7197	Halifax
Canada	Site Reference ID/Investigator# 3883	Hamilton
Canada	Site Reference ID/Investigator# 3884	Hamilton
Canada	Site Reference ID/Investigator# 3903	Montreal
Canada	Site Reference ID/Investigator# 3907	Montreal
Canada	Site Reference ID/Investigator# 5178	Ottawa
Canada	Site Reference ID/Investigator# 3904	Richmond
Canada	Site Reference ID/Investigator# 3912	Sainte-Foy, Quebec
Canada	Site Reference ID/Investigator# 3901	Sarnia
Canada	Site Reference ID/Investigator# 3906	St. John's
Canada	Site Reference ID/Investigator# 6542	Toronto
Canada	Site Reference ID/Investigator# 3882	Victoria
Canada	Site Reference ID/Investigator# 5616	Windsor
Canada	Site Reference ID/Investigator# 3905	Winnipeg
Canada	Site Reference ID/Investigator# 5847	Winnipeg
Czech Republic	Site Reference ID/Investigator# 3968	Brno
Czech Republic	Site Reference ID/Investigator# 3971	Hradec Kralove
Czech Republic	Site Reference ID/Investigator# 5559	Ostrava
Czech Republic	Site Reference ID/Investigator# 3969	Prague 2
Czech Republic	Site Reference ID/Investigator# 5548	Uherske Hradiste
France	Site Reference ID/Investigator# 3982	Amiens
France	Site Reference ID/Investigator# 3979	Le Mans
France	Site Reference ID/Investigator# 3983	Paris Cedex 14
France	Site Reference ID/Investigator# 3918	Strasbourg
Germany	Site Reference ID/Investigator# 3926	Bad Nauheim
Germany	Site Reference ID/Investigator# 3928	Berlin-Buch
Germany	Site Reference ID/Investigator# 3978	Damp
Germany	Site Reference ID/Investigator# 3924	Duesseldorf
Germany	Site Reference ID/Investigator# 3965	Frankfurt
Germany	Site Reference ID/Investigator# 3927	Frankfurt/Main
Germany	Site Reference ID/Investigator# 3925	Freiburg
Germany	Site Reference ID/Investigator# 4291	Halle
Germany	Site Reference ID/Investigator# 8489	Hofheim
Germany	Site Reference ID/Investigator# 3923	Munich
Germany	Site Reference ID/Investigator# 8483	Osnabrueck
Germany	Site Reference ID/Investigator# 8486	Ratingen
Germany	Site Reference ID/Investigator# 3919	Vogelsang-Gommern
Germany	Site Reference ID/Investigator# 6637	Zerbst
Hungary	Site Reference ID/Investigator# 3921	Budapest
Hungary	Site Reference ID/Investigator# 3922	Budapest
Hungary	Site Reference ID/Investigator# 3920	Debrecen
Mexico	Site Reference ID/Investigator# 3824	Aguascallentes
Mexico	Site Reference ID/Investigator# 3822	Leon, Guanajuato
Mexico	Site Reference ID/Investigator# 3823	Mexico City
Mexico	Site Reference ID/Investigator# 3825	Mexico City
Mexico	Site Reference ID/Investigator# 3890	Mexico City
Mexico	Site Reference ID/Investigator# 3891	Mexico City
Mexico	Site Reference ID/Investigator# 3951	Mexico City
Netherlands	Site Reference ID/Investigator# 3947	Arnem
Netherlands	Site Reference ID/Investigator# 3948	Hilversum
New Zealand	Site Reference ID/Investigator# 8485	Auckland 6
New Zealand	Site Reference ID/Investigator# 8488	Hamilton
New Zealand	Site Reference ID/Investigator# 8496	Timaru
New Zealand	Site Reference ID/Investigator# 8511	Wellington
Norway	Site Reference ID/Investigator# 7607	Alesund
Norway	Site Reference ID/Investigator# 7935	Kristiansand S
Norway	Site Reference ID/Investigator# 7506	Levanger
Norway	Site Reference ID/Investigator# 7511	Lillehammer
Norway	Site Reference ID/Investigator# 7500	Trondheim
Poland	Site Reference ID/Investigator# 3963	Bydgoszcz
Poland	Site Reference ID/Investigator# 3962	Katowice
Poland	Site Reference ID/Investigator# 5560	Lublin
Poland	Site Reference ID/Investigator# 3961	Wroclaw
Puerto Rico	Site Reference ID/Investigator# 3944	Caguas
Puerto Rico	Site Reference ID/Investigator# 3937	Ponce
Puerto Rico	Site Reference ID/Investigator# 3934	San Juan
Puerto Rico	Site Reference ID/Investigator# 3935	San Juan
Slovakia	Site Reference ID/Investigator# 3959	Piestany
Slovakia	Site Reference ID/Investigator# 3960	Piestany
South Africa	Site Reference ID/Investigator# 7177	Berea, Durban
South Africa	Site Reference ID/Investigator# 7175	Cape Town
South Africa	Site Reference ID/Investigator# 7178	Cape Town
South Africa	Site Reference ID/Investigator# 7176	Port Elizabeth
South Africa	Site Reference ID/Investigator# 7172	Pretoria
South Africa	Site Reference ID/Investigator# 7174	Soweto
Spain	Site Reference ID/Investigator# 3955	A Coruna
Spain	Site Reference ID/Investigator# 13661	Bilbao
Spain	Site Reference ID/Investigator# 3930	Elche (Alicante)
Spain	Site Reference ID/Investigator# 3931	Madrid
Spain	Site Reference ID/Investigator# 3943	Madrid
Spain	Site Reference ID/Investigator# 3956	Madrid
Spain	Site Reference ID/Investigator# 8524	Madrid
Spain	Site Reference ID/Investigator# 3957	Oviedo
Spain	Site Reference ID/Investigator# 3954	Santiago de Compostela
Spain	Site Reference ID/Investigator# 3932	Zaragoza
Sweden	Site Reference ID/Investigator# 4015	Eskilstuna
Sweden	Site Reference ID/Investigator# 3984	Falun
Sweden	Site Reference ID/Investigator# 4016	Malmoe
Sweden	Site Reference ID/Investigator# 4014	Stockholm
Sweden	Site Reference ID/Investigator# 4017	Uppsala
United Kingdom	Site Reference ID/Investigator# 4012	Bath
United Kingdom	Site Reference ID/Investigator# 8495	Huddersfield
United Kingdom	Site Reference ID/Investigator# 4048	Leeds
United Kingdom	Site Reference ID/Investigator# 4013	London
United Kingdom	Site Reference ID/Investigator# 4046	Newcastle upon Tyne
United Kingdom	Site Reference ID/Investigator# 4047	Oxford
United Kingdom	Site Reference ID/Investigator# 3985	Southampton
United Kingdom	Site Reference ID/Investigator# 7977	York
United States	Site Reference ID/Investigator# 4544	Albuquerque	New Mexico
United States	Site Reference ID/Investigator# 6229	Aventura	Florida
United States	Site Reference ID/Investigator# 6227	Bend	Oregon
United States	Site Reference ID/Investigator# 4547	Birmingham	Alabama
United States	Site Reference ID/Investigator# 4560	Birmingham	Alabama
United States	Site Reference ID/Investigator# 12821	Bronx	New York
United States	Site Reference ID/Investigator# 4533	Charleston	South Carolina
United States	Site Reference ID/Investigator# 4548	Chicago	Illinois
United States	Site Reference ID/Investigator# 4536	Dallas	Texas
United States	Site Reference ID/Investigator# 4559	Denver	Colorado
United States	Site Reference ID/Investigator# 4561	Dover	New Hampshire
United States	Site Reference ID/Investigator# 4546	Duncansville	Pennsylvania
United States	Site Reference ID/Investigator# 6417	Fall River	Massachusetts
United States	Site Reference ID/Investigator# 11222	Freehold	New Jersey
United States	Site Reference ID/Investigator# 4545	Glendale	Wisconsin
United States	Site Reference ID/Investigator# 7482	Greenville	South Carolina
United States	Site Reference ID/Investigator# 9323	Hemet	California
United States	Site Reference ID/Investigator# 4538	Houston	Texas
United States	Site Reference ID/Investigator# 6222	Huntsville	Alabama
United States	Site Reference ID/Investigator# 10743	Jackson	Tennessee
United States	Site Reference ID/Investigator# 4568	La Jolla	California
United States	Site Reference ID/Investigator# 10603	Lake Mary	Florida
United States	Site Reference ID/Investigator# 4549	Mayfield Village	Ohio
United States	Site Reference ID/Investigator# 10745	Meridian	Idaho
United States	Site Reference ID/Investigator# 4537	Mobile	Alabama
United States	Site Reference ID/Investigator# 4562	Nashville	Tennessee
United States	Site Reference ID/Investigator# 4572	Oak Creek	Wisconsin
United States	Site Reference ID/Investigator# 9325	Orange Park	Florida
United States	Site Reference ID/Investigator# 4534	Orchard Park	New York
United States	Site Reference ID/Investigator# 4535	Palm Desert	California
United States	Site Reference ID/Investigator# 4550	Palm Harbor	Florida
United States	Site Reference ID/Investigator# 6228	Passaic	New Jersey
United States	Site Reference ID/Investigator# 9324	Plainview	New York
United States	Site Reference ID/Investigator# 6899	San Antonio	Texas
United States	Site Reference ID/Investigator# 4571	Santa Monica	California
United States	Site Reference ID/Investigator# 4570	Sarasota	Florida
United States	Site Reference ID/Investigator# 10744	Seattle	Washington
United States	Site Reference ID/Investigator# 4600	Smithtown	New York
United States	Site Reference ID/Investigator# 4557	Springfield	Illinois
United States	Site Reference ID/Investigator# 4601	Tampa	Florida
United States	Site Reference ID/Investigator# 9271	Torrance	California
United States	Site Reference ID/Investigator# 6758	Tuscaloosa	Alabama
United States	Site Reference ID/Investigator# 6381	Tyler	Texas
United States	Site Reference ID/Investigator# 4552	Vero Beach	Florida
United States	Site Reference ID/Investigator# 10746	Victorville	California
United States	Site Reference ID/Investigator# 4564	West Reading	Pennsylvania
United States	Site Reference ID/Investigator# 4558	Wexford	Pennsylvania
United States	Site Reference ID/Investigator# 10741	Wheaton	Maryland
United States	Site Reference ID/Investigator# 4605	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4	The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.	Week 78	No
Secondary	Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1	The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.	Week 78	No
Secondary	Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78	The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.	Week 78	No
Secondary	Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78	The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.	Week 78	No
Secondary	Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78	For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.	Week 78	No
Secondary	Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78	Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).	Week 78	No
Secondary	Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78	Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).	Week 78	No
Secondary	Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78	Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).	Week 78	No
Secondary	Change From Baseline in DAS28 Score at Week 78	The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.	Baseline to Week 78	No
Secondary	Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78	The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.	Week 78	No
Secondary	Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78	The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.	Week 78	No
Secondary	Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78	The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.	Week 78	No
Secondary	Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78	The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.	Week 78	No
Secondary	Change From Baseline in CDAI Score at Week 78	The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.	Baseline to Week 78	No
Secondary	Change From Baseline in SDAI Score at Week 78	The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.	Baseline to Week 78	No
Secondary	Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78	Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.	Baseline to Week 78	No
Secondary	Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78	In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.	Week 78	No
Secondary	Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78	In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.	Week 78	No
Secondary	Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78	In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.	Week 78	No