Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (OPERA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Post-marketing observational study to determine the effectiveness and patient satisfaction with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization of a Patient Support Program (PSP).


Condition
Rheumatoid Arthritis

Study Type: Observational
Official Title: A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (OPERA Study)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 78 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 78 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 12 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 24 compared to Baseline(change of at least -0.22 in HAQ-DI). [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 36 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 52 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 64 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 64 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: September 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthitis patients receiving adalimumab commercially
All patients will have Rheumatoid Arthritis and will receive adalimumab commercially, with first dose corresponding to Baseline visit.

Detailed Description:

This study is a non-confirmatory study to explore and describe the effectiveness of adalimumab on Rheumatoid Arthritis (RA) treatment course and patient satisfaction over time in context with utilization of a Patient Support Program (PSP). The main objectives are to examine the effectiveness of adalimumab treatment with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR) response criteria, as well as to evaluate the contribution of PSP to disease control, treatment continuation over time, patient's satisfaction, and PSP utilization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Representative disease population selected from rheumatology clinics in the countries selected.

Criteria

Inclusion Criteria:

  • 1. Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit.
  • 2. Patient with a diagnosis of moderate to severe Rheumatoid Arthritis (RA), who has had insufficient response to one or more Disease-Modifying Antirheumatic Drugs (DMARDs), and has a prescription of adalimumab according to the local regulations.
  • 3. Patients must have been evaluated (per local requirements) for tuberculosis risk factors or latent tuberculosis infection.
  • 4. Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to Abbott.

Exclusion Criteria:

  • 1. Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label.
  • 2. Patients treated with > 1 prior biologic Disease-modifying Anti-rheumatic Drug (DMARD) for Rheumatoid Arthritis (RA).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383421

Contacts
Contact: Saskia de Vente +31-620-744-795 saskia.devente@abbvie.com
Contact: Noreen Travers 847-938-1784 noreen.travers@abbvie.com

  Hide Study Locations
Locations
Australia
Site Reference ID/Investigator# 103416 Recruiting
Adelaide, Australia, 5000
Principal Investigator: Site Reference ID/Investigator# 103416         
Site Reference ID/Investigator# 55262 Recruiting
Campsie, Sydney, Australia, 2194
Principal Investigator: Site Reference ID/Investigator# 55262         
Site Reference ID/Investigator# 56428 Recruiting
Coffs Harbour, Australia, 2450
Principal Investigator: Site Reference ID/Investigator# 56428         
Site Reference ID/Investigator# 55263 Recruiting
Fitzroy, Australia, VIC 3065
Principal Investigator: Site Reference ID/Investigator# 55263         
Site Reference ID/Investigator# 56427 Recruiting
Geelong, Australia, 3220
Principal Investigator: Site Reference ID/Investigator# 56427         
Site Reference ID/Investigator# 103435 Withdrawn
Heidelberg West, Australia, 3081
Site Reference ID/Investigator# 103436 Withdrawn
New Lambton, Australia, 2305
Site Reference ID/Investigator# 55264 Withdrawn
New Lambton, Australia, 2305
Site Reference ID/Investigator# 56426 Recruiting
Shenton Park, Australia, 6008
Principal Investigator: Site Reference ID/Investigator# 56426         
Site Reference ID/Investigator# 103415 Recruiting
West Perth, Australia, 6005
Principal Investigator: Site Reference ID/Investigator# 103415         
Belgium
Site Reference ID/Investigator# 56989 Recruiting
Aalst, Belgium, 9300
Principal Investigator: Site Reference ID/Investigator# 56989         
Site Reference ID/Investigator# 59366 Recruiting
Aalst, Belgium, 9300
Principal Investigator: Site Reference ID/Investigator# 59366         
Site Reference ID/Investigator# 57009 Not yet recruiting
Bouge, Belgium, 5004
Principal Investigator: Site Reference ID/Investigator# 57009         
Site Reference ID/Investigator# 56984 Recruiting
Bruges, Belgium, 8000
Principal Investigator: Site Reference ID/Investigator# 56984         
Site Reference ID/Investigator# 76473 Not yet recruiting
Brussels, Belgium, 1081
Principal Investigator: Site Reference ID/Investigator# 76473         
Site Reference ID/Investigator# 57016 Withdrawn
Brussels, Belgium, 1190
Site Reference ID/Investigator# 57011 Recruiting
Brussels, Belgium, 1000
Principal Investigator: Site Reference ID/Investigator# 57011         
Site Reference ID/Investigator# 57018 Not yet recruiting
Brussels, Belgium, 1190
Principal Investigator: Site Reference ID/Investigator# 57018         
Site Reference ID/Investigator# 57020 Recruiting
Brussels, Belgium, 1040
Principal Investigator: Site Reference ID/Investigator# 57020         
Site Reference ID/Investigator# 57019 Recruiting
Ceroux-Mousty, Belgium, 1341
Principal Investigator: Site Reference ID/Investigator# 57019         
Site Reference ID/Investigator# 57023 Recruiting
Champion, Belgium, 5020
Principal Investigator: Site Reference ID/Investigator# 57023         
Site Reference ID/Investigator# 57017 Not yet recruiting
Charleroi, Belgium, 6000
Principal Investigator: Site Reference ID/Investigator# 57017         
Site Reference ID/Investigator# 57015 Not yet recruiting
Dinant, Belgium, 5500
Principal Investigator: Site Reference ID/Investigator# 57015         
Site Reference ID/Investigator# 56988 Recruiting
Erembodegem, Belgium, 9320
Principal Investigator: Site Reference ID/Investigator# 56988         
Site Reference ID/Investigator# 56990 Recruiting
Genk, Belgium, 3600
Principal Investigator: Site Reference ID/Investigator# 56990         
Site Reference ID/Investigator# 57004 Recruiting
Genk, Belgium, 3600
Principal Investigator: Site Reference ID/Investigator# 57004         
Site Reference ID/Investigator# 56987 Recruiting
Gistel, Belgium, 8470
Principal Investigator: Site Reference ID/Investigator# 56987         
Site Reference ID/Investigator# 60302 Recruiting
Heist-op-den-Berg, Belgium, 2220
Principal Investigator: Site Reference ID/Investigator# 60302         
Site Reference ID/Investigator# 57012 Recruiting
Heusy, Belgium, 4802
Principal Investigator: Site Reference ID/Investigator# 57012         
Site Reference ID/Investigator# 57010 Recruiting
La Louviere, Belgium, 7100
Principal Investigator: Site Reference ID/Investigator# 57010         
Site Reference ID/Investigator# 56986 Withdrawn
Malle, Belgium, 2390
Site Reference ID/Investigator# 57006 Recruiting
Mechelen, Belgium, 2800
Principal Investigator: Site Reference ID/Investigator# 57006         
Site Reference ID/Investigator# 57014 Recruiting
Mons, Belgium, 7000
Principal Investigator: Site Reference ID/Investigator# 57014         
Site Reference ID/Investigator# 57008 Recruiting
Nalinnes, Belgium, 6120
Principal Investigator: Site Reference ID/Investigator# 57008         
Site Reference ID/Investigator# 75953 Not yet recruiting
Namur, Belgium, 5000
Principal Investigator: Site Reference ID/Investigator# 75953         
Site Reference ID/Investigator# 73613 Recruiting
Neupre Plainevaux, Belgium, 4122
Principal Investigator: Site Reference ID/Investigator# 73613         
Site Reference ID/Investigator# 56991 Recruiting
Oudenaarde, Belgium, 9700
Principal Investigator: Site Reference ID/Investigator# 56991         
Site Reference ID/Investigator# 59022 Recruiting
Roeselare, Belgium, 8800
Principal Investigator: Site Reference ID/Investigator# 59022         
Site Reference ID/Investigator# 57003 Recruiting
Sint-Niklaas, Belgium, 9100
Principal Investigator: Site Reference ID/Investigator# 57003         
Site Reference ID/Investigator# 56992 Recruiting
Sint-Niklaas, Belgium, 9100
Principal Investigator: Site Reference ID/Investigator# 56992         
Site Reference ID/Investigator# 57005 Withdrawn
Turnhout, Belgium, 2300
Site Reference ID/Investigator# 57007 Recruiting
Waterloo, Belgium, 1410
Principal Investigator: Site Reference ID/Investigator# 57007         
Site Reference ID/Investigator# 56985 Recruiting
Wilrijk, Belgium, 2610
Principal Investigator: Site Reference ID/Investigator# 56985         
Canada
Site Reference ID/Investigator# 55223 Withdrawn
Calgary, Canada, T2N 4N1
Site Reference ID/Investigator# 55224 Withdrawn
Hamilton, Canada, L8N 1Y2
Site Reference ID/Investigator# 59222 Withdrawn
Montreal, Canada, H2L 1S6
Site Reference ID/Investigator# 55155 Withdrawn
Montreal, Canada
Site Reference ID/Investigator# 55222 Withdrawn
Ottawa, Canada, K1S 1C2
Site Reference ID/Investigator# 55153 Withdrawn
Sainte-Foy, Quebec, Canada, G1W 4R4
Site Reference ID/Investigator# 55154 Withdrawn
Saskatoon, Canada, S7K 0H6
Site Reference ID/Investigator# 55225 Withdrawn
St. John, Canada, E2L 4L2
Czech Republic
Site Reference ID/Investigator# 55810 Recruiting
Brno, Czech Republic, 63800
Principal Investigator: Site Reference ID/Investigator# 55810         
Site Reference ID/Investigator# 55812 Recruiting
Bruntal, Czech Republic, 79201
Principal Investigator: Site Reference ID/Investigator# 55812         
Site Reference ID/Investigator# 55813 Withdrawn
Ceske Budejovice, Czech Republic, 37001
Site Reference ID/Investigator# 55807 Recruiting
Chomutov, Czech Republic, 43012
Principal Investigator: Site Reference ID/Investigator# 55807         
Site Reference ID/Investigator# 55817 Recruiting
Hlucin, Czech Republic, 748 01
Principal Investigator: Site Reference ID/Investigator# 55817         
Site Reference ID/Investigator# 55815 Recruiting
Jihlava, Czech Republic, 58633
Principal Investigator: Site Reference ID/Investigator# 55815         
Site Reference ID/Investigator# 55809 Recruiting
Kromeriz, Czech Republic, 76701
Principal Investigator: Site Reference ID/Investigator# 55809         
Site Reference ID/Investigator# 55811 Recruiting
Ostrava, Czech Republic, 72200
Principal Investigator: Site Reference ID/Investigator# 55811         
Site Reference ID/Investigator# 55816 Recruiting
Pardubice, Czech Republic, 530 02
Principal Investigator: Site Reference ID/Investigator# 55816         
Site Reference ID/Investigator# 105615 Not yet recruiting
Plzen, Czech Republic, 30599
Principal Investigator: Site Reference ID/Investigator# 105615         
Site Reference ID/Investigator# 55808 Withdrawn
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 101335 Recruiting
Prague 5, Czech Republic, 150 06
Principal Investigator: Site Reference ID/Investigator# 101335         
Site Reference ID/Investigator# 55818 Withdrawn
Sokolov, Czech Republic, 35601
Site Reference ID/Investigator# 55814 Recruiting
Uherske Hradiste, Czech Republic, 686 01
Principal Investigator: Site Reference ID/Investigator# 55814         
Site Reference ID/Investigator# 55806 Recruiting
Zlin, Czech Republic, 76001
Principal Investigator: Site Reference ID/Investigator# 55806         
France
Site Reference ID/Investigator# 55499 Recruiting
Amiens, France, 80054
Principal Investigator: Site Reference ID/Investigator# 55499         
Site Reference ID/Investigator# 55506 Not yet recruiting
Berck Cedex, France, 62608
Principal Investigator: Site Reference ID/Investigator# 55506         
Site Reference ID/Investigator# 55510 Withdrawn
Brest, France, 29609
Site Reference ID/Investigator# 55505 Recruiting
Caen, France, 14033
Principal Investigator: Site Reference ID/Investigator# 55505         
Site Reference ID/Investigator# 55493 Recruiting
Cahors, France, 46005
Principal Investigator: Site Reference ID/Investigator# 55493         
Site Reference ID/Investigator# 55511 Recruiting
Clermont-Ferrand, France, 63003
Principal Investigator: Site Reference ID/Investigator# 55511         
Site Reference ID/Investigator# 55509 Recruiting
Dreux, France, 28102
Principal Investigator: Site Reference ID/Investigator# 55509         
Site Reference ID/Investigator# 55502 Recruiting
Lille, France, 59037
Principal Investigator: Site Reference ID/Investigator# 55502         
Site Reference ID/Investigator# 55503 Withdrawn
Lomme, France, 59462
Site Reference ID/Investigator# 55492 Withdrawn
Marseilles, France, 13285
Site Reference ID/Investigator# 55495 Withdrawn
Monaco, France, MC98012
Site Reference ID/Investigator# 55497 Withdrawn
Montpellier Cedex 5, France, 34295
Site Reference ID/Investigator# 55507 Recruiting
Nantes Cedex 1, France, 44093
Principal Investigator: Site Reference ID/Investigator# 55507         
Site Reference ID/Investigator# 55504 Recruiting
Paris Cedex 10, France, 75475
Principal Investigator: Site Reference ID/Investigator# 55504         
Site Reference ID/Investigator# 55501 Not yet recruiting
Paris Cedex 13, France, 75651
Principal Investigator: Site Reference ID/Investigator# 55501         
Site Reference ID/Investigator# 55508 Not yet recruiting
Rennes, France, 35056
Principal Investigator: Site Reference ID/Investigator# 55508         
Site Reference ID/Investigator# 55498 Not yet recruiting
Toulouse, France, TSA 40031
Principal Investigator: Site Reference ID/Investigator# 55498         
Site Reference ID/Investigator# 55496 Recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Site Reference ID/Investigator# 55496         
Germany
Site Reference ID/Investigator# 56686 Recruiting
Bernau, Germany, 16321
Principal Investigator: Site Reference ID/Investigator# 56686         
Site Reference ID/Investigator# 56691 Recruiting
Blaubeuren, Germany, 89143
Principal Investigator: Site Reference ID/Investigator# 56691         
Site Reference ID/Investigator# 56684 Withdrawn
Chemnitz, Germany, D-09130
Site Reference ID/Investigator# 56692 Recruiting
Duesseldorf, Germany, 40211
Principal Investigator: Site Reference ID/Investigator# 56692         
Site Reference ID/Investigator# 56683 Withdrawn
Frankfurt, Germany, 60528
Site Reference ID/Investigator# 56891 Recruiting
Goslar, Germany, 38642
Principal Investigator: Site Reference ID/Investigator# 56891         
Site Reference ID/Investigator# 56688 Recruiting
Haldensleben, Germany, 39340
Principal Investigator: Site Reference ID/Investigator# 56688         
Site Reference ID/Investigator# 56687 Recruiting
Halle, Germany, 06128
Principal Investigator: Site Reference ID/Investigator# 56687         
Site Reference ID/Investigator# 56685 Recruiting
Hoyerswerda, Germany, 02977
Principal Investigator: Site Reference ID/Investigator# 56685         
Site Reference ID/Investigator# 56864 Withdrawn
Neubrandenburg, Germany, 17033
Site Reference ID/Investigator# 56690 Recruiting
Offenburg, Germany, 77652
Principal Investigator: Site Reference ID/Investigator# 56690         
Site Reference ID/Investigator# 56693 Recruiting
Ratingen, Germany, 40882
Principal Investigator: Site Reference ID/Investigator# 56693         
Site Reference ID/Investigator# 56689 Recruiting
Rostock, Germany, 18059
Principal Investigator: Site Reference ID/Investigator# 56689         
Site Reference ID/Investigator# 56862 Recruiting
Seesen, Germany, 38723
Principal Investigator: Site Reference ID/Investigator# 56862         
Greece
Site Reference ID/Investigator# 55427 Recruiting
Athens, Greece, 11527
Principal Investigator: Site Reference ID/Investigator# 55427         
Site Reference ID/Investigator# 122695 Not yet recruiting
Athens, Greece, 15126
Principal Investigator: Site Reference ID/Investigator# 122695         
Site Reference ID/Investigator# 71619 Recruiting
Athens, Greece, 11527
Principal Investigator: Site Reference ID/Investigator# 71619         
Site Reference ID/Investigator# 122696 Not yet recruiting
Athens, Greece, 11527
Principal Investigator: Site Reference ID/Investigator# 122696         
Site Reference ID/Investigator# 55429 Recruiting
Athens, Greece, 11527
Principal Investigator: Site Reference ID/Investigator# 55429         
Site Reference ID/Investigator# 55428 Not yet recruiting
Haidiari, Greece, 12462
Principal Investigator: Site Reference ID/Investigator# 55428         
Site Reference ID/Investigator# 55422 Recruiting
Ioanina, Greece, 45500
Principal Investigator: Site Reference ID/Investigator# 55422         
Site Reference ID/Investigator# 55425 Recruiting
Larissa, Greece, 411 10
Principal Investigator: Site Reference ID/Investigator# 55425         
Site Reference ID/Investigator# 55423 Not yet recruiting
Thessaloniki, Greece, 54642
Principal Investigator: Site Reference ID/Investigator# 55423         
Site Reference ID/Investigator# 55421 Withdrawn
Thessaloniki, Greece, 54642
Site Reference ID/Investigator# 55424 Recruiting
Thessaloniki, Greece, 57010
Principal Investigator: Site Reference ID/Investigator# 55424         
Site Reference ID/Investigator# 122715 Recruiting
Thessaloniki, Greece, 56429
Principal Investigator: Site Reference ID/Investigator# 122715         
Site Reference ID/Investigator# 55426 Completed
Thessaloniki, Greece, 54636
Israel
Site Reference ID/Investigator# 75807 Withdrawn
Ashkelon, Israel, 78287
Site Reference ID/Investigator# 75805 Withdrawn
Hadera, Israel, 38100
Site Reference ID/Investigator# 75806 Recruiting
Haifa, Israel, 31096
Principal Investigator: Site Reference ID/Investigator# 75806         
Site Reference ID/Investigator# 55564 Recruiting
Haifa, Israel, 31038
Principal Investigator: Site Reference ID/Investigator# 55564         
Site Reference ID/Investigator# 55565 Withdrawn
Haifa, Israel, 34362
Site Reference ID/Investigator# 55570 Withdrawn
Jerusalem, Israel, 97891
Site Reference ID/Investigator# 97335 Not yet recruiting
Jerusalem, Israel, 91031
Principal Investigator: Site Reference ID/Investigator# 97335         
Site Reference ID/Investigator# 55568 Recruiting
Petach Tiqwa, Israel, 49100
Principal Investigator: Site Reference ID/Investigator# 55568         
Site Reference ID/Investigator# 55566 Recruiting
Tel Aviv, Israel, 64239
Principal Investigator: Site Reference ID/Investigator# 55566         
Site Reference ID/Investigator# 55569 Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Site Reference ID/Investigator# 55569         
Site Reference ID/Investigator# 55567 Recruiting
Zrifin, Israel, 70300
Principal Investigator: Site Reference ID/Investigator# 55567         
Mexico
Site Reference ID/Investigator# 55265 Recruiting
Chihuahua, Mexico, 31000
Principal Investigator: Site Reference ID/Investigator# 55265         
Site Reference ID/Investigator# 55267 Recruiting
Chihuahua, Mexico, 31000
Principal Investigator: Site Reference ID/Investigator# 55267         
Site Reference ID/Investigator# 55269 Recruiting
Guadalajara, Jalisco, Mexico, 44620
Principal Investigator: Site Reference ID/Investigator# 55269         
Site Reference ID/Investigator# 59382 Withdrawn
Merida, Mexico, 97000
Site Reference ID/Investigator# 55268 Recruiting
Mexico City, Mexico, 04030
Principal Investigator: Site Reference ID/Investigator# 55268         
Site Reference ID/Investigator# 129043 Not yet recruiting
Mexico City, Mexico, CP 03100
Principal Investigator: Site Reference ID/Investigator# 129043         
Site Reference ID/Investigator# 55266 Withdrawn
Mexico City, Mexico, 11850
Site Reference ID/Investigator# 76153 Recruiting
Monterrey, NL, Mexico, 64060
Principal Investigator: Site Reference ID/Investigator# 76153         
Site Reference ID/Investigator# 106595 Recruiting
Monterrey, NL, Mexico, 64600
Principal Investigator: Site Reference ID/Investigator# 106595         
Netherlands
Site Reference ID/Investigator# 55283 Recruiting
Alkmaar, Netherlands, 1815 JD
Principal Investigator: Site Reference ID/Investigator# 55283         
Site Reference ID/Investigator# 55285 Recruiting
Gouda, Netherlands, 2803 HH
Principal Investigator: Site Reference ID/Investigator# 55285         
Site Reference ID/Investigator# 55287 Recruiting
Leeuwarden, Netherlands, 8934 AD
Principal Investigator: Site Reference ID/Investigator# 55287         
Site Reference ID/Investigator# 55284 Recruiting
Rotterdam, Netherlands, 3079 DZ
Principal Investigator: Site Reference ID/Investigator# 55284         
Portugal
Site Reference ID/Investigator# 55200 Withdrawn
Almada, Portugal, 2801-951
Site Reference ID/Investigator# 55201 Not yet recruiting
Coimbra, Portugal, 3000 - 075
Principal Investigator: Site Reference ID/Investigator# 55201         
Site Reference ID/Investigator# 55204 Recruiting
Lisbon, Portugal, 1050-034
Principal Investigator: Site Reference ID/Investigator# 55204         
Site Reference ID/Investigator# 55203 Not yet recruiting
Lisbon, Portugal, 1169-050
Principal Investigator: Site Reference ID/Investigator# 55203         
Site Reference ID/Investigator# 55207 Withdrawn
Lisbon, Portugal, 1349-019
Site Reference ID/Investigator# 55205 Withdrawn
Lisbon, Portugal, 2720-276
Site Reference ID/Investigator# 55199 Recruiting
Ponte de Lima, Portugal, 4990-041
Principal Investigator: Site Reference ID/Investigator# 55199         
Site Reference ID/Investigator# 128344 Not yet recruiting
Ponte de Lima, Portugal, 4990-041
Principal Investigator: Site Reference ID/Investigator# 128344         
Site Reference ID/Investigator# 55208 Not yet recruiting
Porto, Portugal, 4099-001
Principal Investigator: Site Reference ID/Investigator# 55208         
Site Reference ID/Investigator# 55206 Withdrawn
Porto, Portugal, 4200-319
Site Reference ID/Investigator# 55209 Not yet recruiting
S. Martinho do Bispo (Coimbra), Portugal, 3041-801
Principal Investigator: Site Reference ID/Investigator# 55209         
Site Reference ID/Investigator# 55202 Recruiting
Viseu, Portugal, 3504-509
Principal Investigator: Site Reference ID/Investigator# 55202         
Puerto Rico
Site Reference ID/Investigator# 123075 Recruiting
Bayamon, Puerto Rico, 00961-7049
Principal Investigator: Site Reference ID/Investigator# 123075         
Site Reference ID/Investigator# 54943 Withdrawn
Bayamón, Puerto Rico, 00960
Site Reference ID/Investigator# 55487 Recruiting
Caguas, Puerto Rico, 00725
Principal Investigator: Site Reference ID/Investigator# 55487         
Site Reference ID/Investigator# 63702 Withdrawn
Hato Rey, Puerto Rico, 00918
Site Reference ID/Investigator# 55490 Withdrawn
Mayaguez, Puerto Rico, 00680
Site Reference ID/Investigator# 78453 Recruiting
Mayaguez, Puerto Rico, 00680
Principal Investigator: Site Reference ID/Investigator# 78453         
Site Reference ID/Investigator# 55485 Recruiting
Ponce, Puerto Rico, 00717-1321
Principal Investigator: Site Reference ID/Investigator# 55485         
Site Reference ID/Investigator# 55486 Withdrawn
Rio Piedras, Puerto Rico, 00921
Site Reference ID/Investigator# 55489 Withdrawn
San Juan, Puerto Rico, 00907
Site Reference ID/Investigator# 54942 Recruiting
Vega Baja, Puerto Rico, 00693
Principal Investigator: Site Reference ID/Investigator# 54942         
Slovakia
Site Reference ID/Investigator# 55144 Recruiting
Banska Bystrica, Slovakia, 975 17
Principal Investigator: Site Reference ID/Investigator# 55144         
Site Reference ID/Investigator# 55150 Recruiting
Bratislava, Slovakia, 826 06
Principal Investigator: Site Reference ID/Investigator# 55150         
Site Reference ID/Investigator# 55148 Recruiting
Kosice, Slovakia, 040 01
Principal Investigator: Site Reference ID/Investigator# 55148         
Site Reference ID/Investigator# 55147 Recruiting
Kosice, Slovakia, 040 11
Principal Investigator: Site Reference ID/Investigator# 55147         
Site Reference ID/Investigator# 55146 Recruiting
Piestany, Slovakia, 922 12
Principal Investigator: Site Reference ID/Investigator# 55146         
Site Reference ID/Investigator# 55145 Recruiting
Piestany, Slovakia, 92112
Principal Investigator: Site Reference ID/Investigator# 55145         
Site Reference ID/Investigator# 55152 Recruiting
Piestany, Slovakia, 928 12
Principal Investigator: Site Reference ID/Investigator# 55152         
Site Reference ID/Investigator# 55151 Withdrawn
Piestany, Slovakia, 927 12
Site Reference ID/Investigator# 55149 Recruiting
Piestany, Slovakia, 925 12
Principal Investigator: Site Reference ID/Investigator# 55149         
Spain
Site Reference ID/Investigator# 55639 Withdrawn
A Coruna, Spain, 15006
Site Reference ID/Investigator# 55642 Withdrawn
Barcelona, Spain, 08035
Site Reference ID/Investigator# 58414 Withdrawn
El Palmar, Spain, 30120
Site Reference ID/Investigator# 57624 Withdrawn
Gijon, Spain, 33212
Site Reference ID/Investigator# 61902 Withdrawn
Laredo, Spain, 39770
Site Reference ID/Investigator# 55640 Withdrawn
Lugo, Spain, 27033
Site Reference ID/Investigator# 69182 Withdrawn
Manacor, Spain, 07500
Site Reference ID/Investigator# 56383 Withdrawn
Plasencia, Spain, 10600
Site Reference ID/Investigator# 66506 Withdrawn
Sabadell, Spain, 08208
Site Reference ID/Investigator# 58413 Withdrawn
Santander, Spain, 39008
Site Reference ID/Investigator# 55641 Withdrawn
Vigo, Spain, 36214
Site Reference ID/Investigator# 55643 Withdrawn
Villajoyosa, Spain, 03570
Switzerland
Site Reference ID/Investigator# 74857 Withdrawn
Aarau, Switzerland, 5001
Site Reference ID/Investigator# 65962 Recruiting
Chur, Switzerland, 7000
Principal Investigator: Site Reference ID/Investigator# 65962         
Site Reference ID/Investigator# 74855 Recruiting
Clarens - Montreux, Switzerland, 1815
Principal Investigator: Site Reference ID/Investigator# 74855         
Site Reference ID/Investigator# 74856 Recruiting
Lausanne, Switzerland, 1005
Principal Investigator: Site Reference ID/Investigator# 74856         
United Kingdom
Site Reference ID/Investigator# 55434 Recruiting
Barnsley, United Kingdom, S75 2EP
Principal Investigator: Site Reference ID/Investigator# 55434         
Site Reference ID/Investigator# 55438 Recruiting
Basingstoke, United Kingdom, RG24 9NA
Principal Investigator: Site Reference ID/Investigator# 55438         
Site Reference ID/Investigator# 61696 Recruiting
Bury St Edmunds, United Kingdom, IP33 2QZ
Principal Investigator: Site Reference ID/Investigator# 61696         
Site Reference ID/Investigator# 55433 Recruiting
Cambridge, United Kingdom, CB2 0QQ
Principal Investigator: Site Reference ID/Investigator# 55433         
Site Reference ID/Investigator# 55440 Withdrawn
Carshalton, United Kingdom, SM5 1AA
Site Reference ID/Investigator# 61695 Withdrawn
Colchester, United Kingdom, C04 5JL
Site Reference ID/Investigator# 55435 Recruiting
Dewsbury, United Kingdom, WF13 4HS
Principal Investigator: Site Reference ID/Investigator# 55435         
Site Reference ID/Investigator# 55436 Recruiting
Glasgow, United Kingdom, G120YN
Principal Investigator: Site Reference ID/Investigator# 55436         
Site Reference ID/Investigator# 55431 Recruiting
Harrogate, United Kingdom, HG2 7SX
Principal Investigator: Site Reference ID/Investigator# 55431         
Site Reference ID/Investigator# 55437 Withdrawn
Leeds, United Kingdom, LS7 4SA
Site Reference ID/Investigator# 55514 Recruiting
Leicester, United Kingdom, LE1 5WW
Principal Investigator: Site Reference ID/Investigator# 55514         
Site Reference ID/Investigator# 119776 Recruiting
London, United Kingdom, NW3 2Qg
Principal Investigator: Site Reference ID/Investigator# 119776         
Site Reference ID/Investigator# 55439 Withdrawn
Merthyr Tydfil, United Kingdom, CF47 9DT
Site Reference ID/Investigator# 55430 Withdrawn
Newcastle upon Tyne, United Kingdom, NE7 7DN
Site Reference ID/Investigator# 55432 Withdrawn
Portsmouth, United Kingdom, P06 3LY
Site Reference ID/Investigator# 119777 Recruiting
Warrington, United Kingdom, WA5 1QG
Principal Investigator: Site Reference ID/Investigator# 119777         
Site Reference ID/Investigator# 57306 Recruiting
Westcliff on Sea, United Kingdom, SS0 0RY
Principal Investigator: Site Reference ID/Investigator# 57306         
Site Reference ID/Investigator# 119775 Recruiting
Wigan, United Kingdom, WN6 9EP
Principal Investigator: Site Reference ID/Investigator# 119775         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jasmina Kalabic, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01383421     History of Changes
Other Study ID Numbers: P12-072
Study First Received: June 26, 2011
Last Updated: July 22, 2014
Health Authority: Slovakia: State Institute for Drug Control
Canada: Health Canada
Mexico: Secretaria de Salud
Israel: Ministry of Health
Spain: Ministry of Health and Consumption
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Department of Health
Netherlands: Medicines Evaluation Board (MEB)
Portugal: National Pharmacy and Medicines Institute
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Ministry of Health
Greece: Ministry of Health and Welfare

Keywords provided by AbbVie:
Patient Support Program
adalimumab
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014