Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— ReAlise  

Official title:

A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234884
• Other study ID #: M03-634
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: August 25, 2011
• Start date: September 2003
• Est. completion date: July 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutGreece: National Organization of MedicinesItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Portugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Description:

This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).

Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3435
• 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:

• Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).

• Participants must have been willing to consent to data being collected and provided to Abbott.

Exclusion Criteria:

· Participants with contraindications according to the SmPC.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)

Locations

Country	Name	City	State
Australia	Site Ref # / Investigator 49508	Brisbane	Queensland
Australia	Site Ref # / Investigator 49502	Cairns
Australia	Site Ref # / Investigator 5606	Camperdown	New South Wales
Australia	Site Ref # / Investigator 49504	New Lambton	New South Wales
Australia	Site Ref # / Investigator 49503	West Heidelberg	Victoria
Australia	Site Ref # / Investigator 49505	Woodville	South Australia
Austria	Site Ref # / Investigator 49747	Bad Schallerbach
Austria	Site Ref # / Investigator 49517	Graz
Austria	Site Ref # / Investigator 49521	Graz
Austria	Site Ref # / Investigator 49518	Innsbruck
Austria	Site Ref # / Investigator 49746	Klagenfurt
Austria	Site Ref # / Investigator 49748	Laab im Walde
Austria	Site Ref # / Investigator 49516	Linz
Austria	Site Ref # / Investigator 49523	Oberpullendorf
Austria	Site Ref # / Investigator 49745	St. Poelten
Austria	Site Ref # / Investigator 49519	Stockerau
Austria	Site Ref # / Investigator 49520	Vienna
Austria	Site Ref # / Investigator 4961	Vienna
Belgium	Site Ref # / Investigator 49794	Aalst
Belgium	Site Ref # / Investigator 49817	Antwerp
Belgium	Site Ref # / Investigator 49788	Assebroek
Belgium	Site Ref # / Investigator 49764	Baudour
Belgium	Site Ref # / Investigator 49808	Belsele
Belgium	Site Ref # / Investigator 49806	Bonheiden
Belgium	Site Ref # / Investigator 49809	Bonheiden
Belgium	Site Ref # / Investigator 49798	Braine-l'Alleud
Belgium	Site Ref # / Investigator 49773	Bruges
Belgium	Site Ref # / Investigator 49762	Brussels
Belgium	Site Ref # / Investigator 49763	Brussels
Belgium	Site Ref # / Investigator 49772	Brussels
Belgium	Site Ref # / Investigator 49774	Brussels
Belgium	Site Ref # / Investigator 49791	Brussels
Belgium	Site Ref # / Investigator 49807	Brussels
Belgium	Site Ref # / Investigator 49811	Brussels
Belgium	Site Ref # / Investigator 49780	Chimay
Belgium	Site Ref # / Investigator 49795	Destelbergen
Belgium	Site Ref # / Investigator 49768	Edegem
Belgium	Site Ref # / Investigator 49776	Genk
Belgium	Site Ref # / Investigator 49813	Genk
Belgium	Site Ref # / Investigator 26424	Ghent
Belgium	Site Ref # / Investigator 49766	Gosselies
Belgium	Site Ref # / Investigator 49781	Hamme
Belgium	Site Ref # / Investigator 49810	Hasselt
Belgium	Site Ref # / Investigator 49814	Hasselt
Belgium	Site Ref # / Investigator 49777	Kortrijk
Belgium	Site Ref # / Investigator 49767	La Louviere
Belgium	Site Ref # / Investigator 49801	La Louviere
Belgium	Site Ref # / Investigator 49816	Leuven
Belgium	Site Ref # / Investigator 49789	Liege
Belgium	Site Ref # / Investigator 49775	Lier
Belgium	Site Ref # / Investigator 49778	Lokeren
Belgium	Site Ref # / Investigator 49771	Mechelen
Belgium	Site Ref # / Investigator 49815	Mechelen
Belgium	Site Ref # / Investigator 49796	Merksem
Belgium	Site Ref # / Investigator 49785	Mons
Belgium	Site Ref # / Investigator 49891	Montignies-sur-Sambre
Belgium	Site Ref # / Investigator 49770	Namur
Belgium	Site Ref # / Investigator 49783	Namur
Belgium	Site Ref # / Investigator 49797	Nukerke
Belgium	Site Ref # / Investigator 49787	Oostende
Belgium	Site Ref # / Investigator 49802	Ottignies
Belgium	Site Ref # / Investigator 49793	Sijsele
Belgium	Site Ref # / Investigator 49805	Sint-Niklaas
France	Site Ref # / Investigator 49615	Aix en Provence
France	Site Ref # / Investigator 49332	Aix Les Bains
France	Site Ref # / Investigator 49350	Angers
France	Site Ref # / Investigator 49604	Aulnay Sous Bois
France	Site Ref # / Investigator 49340	Belfort
France	Site Ref # / Investigator 49621	Berck
France	Site Ref # / Investigator 49339	Besancon
France	Site Ref # / Investigator 49351	Bobigny
France	Site Ref # / Investigator 49365	Bordeaux
France	Site Ref # / Investigator 49611	Boulogne Billancourt
France	Site Ref # / Investigator 49622	Bourg en Bresse
France	Site Ref # / Investigator 49329	Brest
France	Site Ref # / Investigator 49334	Caen
France	Site Ref # / Investigator 49358	Cahors
France	Site Ref # / Investigator 49607	Cannes
France	Site Ref # / Investigator 49612	Carcassonne
France	Site Ref # / Investigator 49628	Cherbourg
France	Site Ref # / Investigator 49613	Clermont-Ferrand
France	Site Ref # / Investigator 49624	Colombes
France	Site Ref # / Investigator 49376	Compiegne
France	Site Ref # / Investigator 49356	Corbeil Essonnes
France	Site Ref # / Investigator 49370	Creteil
France	Site Ref # / Investigator 49605	Dijon
France	Site Ref # / Investigator 49608	Gleize
France	Site Ref # / Investigator 49610	Gonesse
France	Site Ref # / Investigator 49361	Grenoble
France	Site Ref # / Investigator 49379	Grenoble
France	Site Ref # / Investigator 49614	La Roche sur Yon
France	Site Ref # / Investigator 49601	La Rochelle
France	Site Ref # / Investigator 49373	Le Kremlin Bicetre
France	Site Ref # / Investigator 49375	Le Mans
France	Site Ref # / Investigator 49325	Libourne
France	Site Ref # / Investigator 49620	Lievin
France	Site Ref # / Investigator 49360	Lille
France	Site Ref # / Investigator 49623	Limoges
France	Site Ref # / Investigator 49333	Lomme
France	Site Ref # / Investigator 49355	Lunel
France	Site Ref # / Investigator 49337	Lyon
France	Site Ref # / Investigator 49363	Lyon
France	Site Ref # / Investigator 49364	Lyon
France	Site Ref # / Investigator 49603	Mantes La Jolie
France	Site Ref # / Investigator 49342	Marseilles
France	Site Ref # / Investigator 49345	Marseilles
France	Site Ref # / Investigator 49362	Marseilles
France	Site Ref # / Investigator 49626	Marseilles
France	Site Ref # / Investigator 49330	Montivilliers
France	Site Ref # / Investigator 49323	Montpellier Cedex 5
France	Site Ref # / Investigator 5590	Mulhouse
France	Site Ref # / Investigator 49374	Nantes Cedex 1
France	Site Ref # / Investigator 49642	Narbonne
France	Site Ref # / Investigator 49353	Nice
France	Site Ref # / Investigator 49618	Orange
France	Site Ref # / Investigator 49331	Orleans
France	Site Ref # / Investigator 49326	Paris
France	Site Ref # / Investigator 49359	Paris
France	Site Ref # / Investigator 49600	Paris
France	Site Ref # / Investigator 49625	Paris
France	Site Ref # / Investigator 49352	Paris Cedex 14
France	Site Ref # / Investigator 49343	Pau
France	Site Ref # / Investigator 49344	Pessac
France	Site Ref # / Investigator 49606	Pierre Benite
France	Site Ref # / Investigator 49602	Poissy
France	Site Ref # / Investigator 49349	Poitiers
France	Site Ref # / Investigator 49627	Provins
France	Site Ref # / Investigator 49382	Reims
France	Site Ref # / Investigator 49328	Rennes
France	Site Ref # / Investigator 49619	Roubaix
France	Site Ref # / Investigator 49372	Rouen
France	Site Ref # / Investigator 49609	Saint Aubin Les Elbeuf
France	Site Ref # / Investigator 49327	Saint Brieuc
France	Site Ref # / Investigator 49336	Saint Maurice
France	Site Ref # / Investigator 49598	Saint-Etienne
France	Site Ref # / Investigator 49346	Strasbourg
France	Site Ref # / Investigator 49366	Thionville
France	Site Ref # / Investigator 49616	Toulon
France	Site Ref # / Investigator 49322	Toulouse
France	Site Ref # / Investigator 49348	Toulouse
France	Site Ref # / Investigator 49324	Tours
France	Site Ref # / Investigator 49617	Valence
France	Site Ref # / Investigator 49371	Valenciennes
France	Site Ref # / Investigator 49629	Vannes
Germany	Site Ref # / Investigator 49573	Aachen
Germany	Site Ref # / Investigator 49433	Berlin
Germany	Site Ref # / Investigator 49454	Berlin
Germany	Site Ref # / Investigator 49480	Berlin
Germany	Site Ref # / Investigator 49705	Berlin
Germany	Site Ref # / Investigator 49577	Bremen
Germany	Site Ref # / Investigator 49451	Chemnitz
Germany	Site Ref # / Investigator 49551	Cologne
Germany	Site Ref # / Investigator 5602	Cottbus
Germany	Site Ref # / Investigator 49441	Damp
Germany	Site Ref # / Investigator 49446	Dresden
Germany	Site Ref # / Investigator 49474	Dresden
Germany	Site Ref # / Investigator 49483	Duisburg
Germany	Site Ref # / Investigator 49455	Erfurt
Germany	Site Ref # / Investigator 49475	Erlangen
Germany	Site Ref # / Investigator 49579	Erlangen
Germany	Site Ref # / Investigator 49481	Essen
Germany	Site Ref # / Investigator 49469	Freiburg
Germany	Site Ref # / Investigator 49711	Freiburg
Germany	Site Ref # / Investigator 49556	Fuerth
Germany	Site Ref # / Investigator 49482	Gyhum
Germany	Site Ref # / Investigator 49422	Halle
Germany	Site Ref # / Investigator 49468	Hamburg
Germany	Site Ref # / Investigator 49552	Hamburg
Germany	Site Ref # / Investigator 49466	Hattingen
Germany	Site Ref # / Investigator 49544	Herrsching
Germany	Site Ref # / Investigator 49548	Hildesheim
Germany	Site Ref # / Investigator 49587	Hofheim
Germany	Site Ref # / Investigator 49447	Jena
Germany	Site Ref # / Investigator 49431	Leipzig
Germany	Site Ref # / Investigator 49424	Ludwigsburg
Germany	Site Ref # / Investigator 49557	Ludwigshafen
Germany	Site Ref # / Investigator 49704	Marl
Germany	Site Ref # / Investigator 49547	Moenchengladbach
Germany	Site Ref # / Investigator 49440	Muenster
Germany	Site Ref # / Investigator 49450	Munich
Germany	Site Ref # / Investigator 49563	Munich
Germany	Site Ref # / Investigator 49442	Passau
Germany	Site Ref # / Investigator 49549	Ratingen
Germany	Site Ref # / Investigator 49708	Rostock
Germany	Site Ref # / Investigator 49558	Schlangenbad
Germany	Site Ref # / Investigator 49445	Sendenhorst
Germany	Site Ref # / Investigator 49437	Stuttgart
Germany	Site Ref # / Investigator 49560	Tuebingen
Germany	Site Ref # / Investigator 49460	Villingen
Germany	Site Ref # / Investigator 49456	Vogelsang-Gommern
Germany	Site Ref # / Investigator 49545	Wuerzburg
Germany	Site Ref # / Investigator 49449	Wuppertal
Greece	Site Ref # / Investigator 49554	Athens
Greece	Site Ref # / Investigator 49565	Athens
Greece	Site Ref # / Investigator 49568	Athens
Greece	Site Ref # / Investigator 49580	Athens
Greece	Site Ref # / Investigator 49583	Athens
Greece	Site Ref # / Investigator 49584	Athens
Greece	Site Ref # / Investigator 49585	Athens
Greece	Site Ref # / Investigator 49564	Heraklion
Greece	Site Ref # / Investigator 49567	Ioannina
Greece	Site Ref # / Investigator 49581	Larisa
Greece	Site Ref # / Investigator 26425	Patras
Greece	Site Ref # / Investigator 49553	Thessaloniki
Greece	Site Ref # / Investigator 49566	Thessaloniki
Greece	Site Ref # / Investigator 49569	Thessaloniki
Greece	Site Ref # / Investigator 49582	Thessaloniki
Italy	Site Ref # / Investigator 49990	Acqui Terme (AL)
Italy	Site Ref # / Investigator 49591	Arenzano (GE)
Italy	Site Ref # / Investigator 49983	Bari
Italy	Site Ref # / Investigator 49593	Bologna
Italy	Site Ref # / Investigator 49980	Brescia
Italy	Site Ref # / Investigator 49986	Cagliari
Italy	Site Ref # / Investigator 50056	Ferrara
Italy	Site Ref # / Investigator 49987	Florence
Italy	Site Ref # / Investigator 49597	Foggia
Italy	Site Ref # / Investigator 49824	Genoa
Italy	Site Ref # / Investigator 50051	Genoa
Italy	Site Ref # / Investigator 49981	Jesi (Ancona)
Italy	Site Ref # / Investigator 49588	Messina
Italy	Site Ref # / Investigator 49596	Milano
Italy	Site Ref # / Investigator 49976	Milano
Italy	Site Ref # / Investigator 50052	Milano
Italy	Site Ref # / Investigator 49985	Modena
Italy	Site Ref # / Investigator 49949	Naples
Italy	Site Ref # / Investigator 49595	Novara
Italy	Site Ref # / Investigator 49947	Padova
Italy	Site Ref # / Investigator 49948	Palermo
Italy	Site Ref # / Investigator 49978	Perugia
Italy	Site Ref # / Investigator 49974	Pescara
Italy	Site Ref # / Investigator 49592	Pisa
Italy	Site Ref # / Investigator 49992	Potenza
Italy	Site Ref # / Investigator 49822	Prato
Italy	Site Ref # / Investigator 49946	Reggio Emilia
Italy	Site Ref # / Investigator 49950	Rome
Italy	Site Ref # / Investigator 49989	Rome
Italy	Site Ref # / Investigator 50057	Rome
Italy	Site Ref # / Investigator 49984	Rozzano
Italy	Site Ref # / Investigator 49991	San Cesario Lecce
Italy	Site Ref # / Investigator 49994	Torino
Italy	Site Ref # / Investigator 49825	Udine
Italy	Site Ref # / Investigator 26422	Valeggio sul Mincio Verona
Italy	Site Ref # / Investigator 49594	Varese
Italy	Site Ref # / Investigator 50055	Verbania Pallanza
Italy	Site Ref # / Investigator 49589	Verona
Italy	Site Ref # / Investigator 50053	Vimercate
Netherlands	Site Ref # / Investigator 49904	Alkmaar
Netherlands	Site Ref # / Investigator 49909	Almere
Netherlands	Site Ref # / Investigator 49831	Amersfoort
Netherlands	Site Ref # / Investigator 49906	Bergen op Zoom
Netherlands	Site Ref # / Investigator 49907	Breda
Netherlands	Site Ref # / Investigator 49905	Den Haag
Netherlands	Site Ref # / Investigator 49920	Den Haag
Netherlands	Site Ref # / Investigator 49910	Den Helder
Netherlands	Site Ref # / Investigator 49902	Goes
Netherlands	Site Ref # / Investigator 49829	Leeuwarden
Netherlands	Site Ref # / Investigator 26426	Rotterdam
Netherlands	Site Ref # / Investigator 49830	Rotterdam
Netherlands	Site Ref # / Investigator 49908	Schiedam
Netherlands	Site Ref # / Investigator 49827	Utrecht
Netherlands	Site Ref # / Investigator 49903	Venlo
Netherlands	Site Ref # / Investigator 49835	Vlissingen
Portugal	Site Ref # / Investigator 49514	Coimbra
Portugal	Site Ref # / Investigator 49509	Lisboa
Portugal	Site Ref # / Investigator 49515	Lisboa
Portugal	Site Ref # / Investigator 49510	Lisbon
Portugal	Site Ref # / Investigator 49513	Lisbon
Portugal	Site Ref # / Investigator 49512	Ponta Delgada-Acores
Portugal	Site Ref # / Investigator 26427	Ponte de Lima
Spain	Site Ref # / Investigator 49653	Alicante
Spain	Site Ref # / Investigator 49662	Asturias
Spain	Site Ref # / Investigator 49645	Barcelona
Spain	Site Ref # / Investigator 49646	Barcelona
Spain	Site Ref # / Investigator 49647	Barcelona
Spain	Site Ref # / Investigator 49649	Barcelona
Spain	Site Ref # / Investigator 49670	Barcelona
Spain	Site Ref # / Investigator 49680	Barcelona
Spain	Site Ref # / Investigator 49684	Barcelona
Spain	Site Ref # / Investigator 49667	Cadiz
Spain	Site Ref # / Investigator 49693	Cadiz
Spain	Site Ref # / Investigator 5594	Castellon de la Plana
Spain	Site Ref # / Investigator 49663	Cordoba
Spain	Site Ref # / Investigator 49652	Elche
Spain	Site Ref # / Investigator 49651	Granada
Spain	Site Ref # / Investigator 49681	Granada
Spain	Site Ref # / Investigator 49695	Guadalajara
Spain	Site Ref # / Investigator 49669	Jaen
Spain	Site Ref # / Investigator 49689	Lerida
Spain	Site Ref # / Investigator 49650	Madrid
Spain	Site Ref # / Investigator 49664	Madrid
Spain	Site Ref # / Investigator 49679	Madrid
Spain	Site Ref # / Investigator 49683	Madrid
Spain	Site Ref # / Investigator 49686	Madrid
Spain	Site Ref # / Investigator 49687	Madrid
Spain	Site Ref # / Investigator 49692	Madrid
Spain	Site Ref # / Investigator 49696	Madrid
Spain	Site Ref # / Investigator 49697	Madrid
Spain	Site Ref # / Investigator 49665	Malaga
Spain	Site Ref # / Investigator 49691	Malaga
Spain	Site Ref # / Investigator 49685	Mostoles-Madrid
Spain	Site Ref # / Investigator 49666	Sant Joan Despi (Barcelona)
Spain	Site Ref # / Investigator 49688	Seville
Spain	Site Ref # / Investigator 49694	Toledo
Spain	Site Ref # / Investigator 49654	Valencia
Spain	Site Ref # / Investigator 49648	Vic (Barcelona)
United Kingdom	Site Ref # / Investigator 49485	Brighton
United Kingdom	Site Ref # / Investigator 49470	Greater Manchester
United Kingdom	Site Ref # / Investigator 49471	Harrogate
United Kingdom	Site Ref # / Investigator 49476	Manchester
United Kingdom	Site Ref # / Investigator 49486	Oxford
United Kingdom	Site Ref # / Investigator 49472	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)	DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	No
Primary	American College of Rheumatology 20% (ACR20) Response Rate	ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	No
Primary	American College of Rheumatology 50% (ACR50) Response Rate	ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	No
Primary	American College of Rheumatology 70% (ACR70) Response Rate	ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	No
Primary	Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)	HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	No