Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: October 10, 2014
Last verified: October 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: 1000
Study Start Date: September 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 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

  Hide Study Locations
Locations
Australia
Site Reference ID/Investigator# 103416
Adelaide, Australia, 5000
Site Reference ID/Investigator# 55262
Campsie, Sydney, Australia, 2194
Site Reference ID/Investigator# 56428
Coffs Harbour, Australia, 2450
Site Reference ID/Investigator# 55263
Fitzroy, Australia, VIC 3065
Site Reference ID/Investigator# 56427
Geelong, Australia, 3220
Site Reference ID/Investigator# 56426
Shenton Park, Australia, 6008
Site Reference ID/Investigator# 103415
West Perth, Australia, 6005
Belgium
Site Reference ID/Investigator# 56989
Aalst, Belgium, 9300
Site Reference ID/Investigator# 59366
Aalst, Belgium, 9300
Site Reference ID/Investigator# 57009
Bouge, Belgium, 5004
Site Reference ID/Investigator# 56984
Bruges, Belgium, 8000
Site Reference ID/Investigator# 57011
Brussels, Belgium, 1000
Site Reference ID/Investigator# 57018
Brussels, Belgium, 1190
Site Reference ID/Investigator# 57020
Brussels, Belgium, 1040
Site Reference ID/Investigator# 76473
Brussels, Belgium, 1081
Site Reference ID/Investigator# 57019
Ceroux-Mousty, Belgium, 1341
Site Reference ID/Investigator# 57023
Champion, Belgium, 5020
Site Reference ID/Investigator# 57017
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 57015
Dinant, Belgium, 5500
Site Reference ID/Investigator# 56988
Erembodegem, Belgium, 9320
Site Reference ID/Investigator# 56990
Genk, Belgium, 3600
Site Reference ID/Investigator# 57004
Genk, Belgium, 3600
Site Reference ID/Investigator# 56987
Gistel, Belgium, 8470
Site Reference ID/Investigator# 60302
Heist-op-den-Berg, Belgium, 2220
Site Reference ID/Investigator# 57012
Heusy, Belgium, 4802
Site Reference ID/Investigator# 57010
La Louviere, Belgium, 7100
Site Reference ID/Investigator# 57006
Mechelen, Belgium, 2800
Site Reference ID/Investigator# 57014
Mons, Belgium, 7000
Site Reference ID/Investigator# 57008
Nalinnes, Belgium, 6120
Site Reference ID/Investigator# 75953
Namur, Belgium, 5000
Site Reference ID/Investigator# 73613
Neupre Plainevaux, Belgium, 4122
Site Reference ID/Investigator# 56991
Oudenaarde, Belgium, 9700
Site Reference ID/Investigator# 59022
Roeselare, Belgium, 8800
Site Reference ID/Investigator# 56992
Sint-Niklaas, Belgium, 9100
Site Reference ID/Investigator# 57003
Sint-Niklaas, Belgium, 9100
Site Reference ID/Investigator# 57007
Waterloo, Belgium, 1410
Site Reference ID/Investigator# 56985
Wilrijk, Belgium, 2610
Czech Republic
Site Reference ID/Investigator# 55810
Brno, Czech Republic, 63800
Site Reference ID/Investigator# 55812
Bruntal, Czech Republic, 79201
Site Reference ID/Investigator# 55807
Chomutov, Czech Republic, 43012
Site Reference ID/Investigator# 55817
Hlucin, Czech Republic, 748 01
Site Reference ID/Investigator# 55815
Jihlava, Czech Republic, 58633
Site Reference ID/Investigator# 55809
Kromeriz, Czech Republic, 76701
Site Reference ID/Investigator# 55811
Ostrava, Czech Republic, 72200
Site Reference ID/Investigator# 55816
Pardubice, Czech Republic, 530 02
Site Reference ID/Investigator# 105615
Plzen, Czech Republic, 30599
Site Reference ID/Investigator# 101335
Prague 5, Czech Republic, 150 06
Site Reference ID/Investigator# 55814
Uherske Hradiste, Czech Republic, 686 01
Site Reference ID/Investigator# 55806
Zlin, Czech Republic, 76001
France
Site Reference ID/Investigator# 55499
Amiens, France, 80054
Site Reference ID/Investigator# 55506
Berck Cedex, France, 62608
Site Reference ID/Investigator# 55505
Caen, France, 14033
Site Reference ID/Investigator# 55493
Cahors, France, 46005
Site Reference ID/Investigator# 55511
Clermont-Ferrand, France, 63003
Site Reference ID/Investigator# 55509
Dreux, France, 28102
Site Reference ID/Investigator# 55502
Lille, France, 59037
Site Reference ID/Investigator# 55507
Nantes Cedex 1, France, 44093
Site Reference ID/Investigator# 55504
Paris Cedex 10, France, 75475
Site Reference ID/Investigator# 55501
Paris Cedex 13, France, 75651
Site Reference ID/Investigator# 55508
Rennes, France, 35056
Site Reference ID/Investigator# 55498
Toulouse, France, TSA 40031
Site Reference ID/Investigator# 55496
Vandoeuvre les Nancy, France, 54511
Germany
Site Reference ID/Investigator# 56686
Bernau, Germany, 16321
Site Reference ID/Investigator# 56691
Blaubeuren, Germany, 89143
Site Reference ID/Investigator# 56692
Duesseldorf, Germany, 40211
Site Reference ID/Investigator# 56891
Goslar, Germany, 38642
Site Reference ID/Investigator# 56688
Haldensleben, Germany, 39340
Site Reference ID/Investigator# 56687
Halle, Germany, 06128
Site Reference ID/Investigator# 56685
Hoyerswerda, Germany, 02977
Site Reference ID/Investigator# 56690
Offenburg, Germany, 77652
Site Reference ID/Investigator# 56693
Ratingen, Germany, 40882
Site Reference ID/Investigator# 56689
Rostock, Germany, 18059
Site Reference ID/Investigator# 56862
Seesen, Germany, 38723
Greece
Site Reference ID/Investigator# 71619
Athens, Greece, 11527
Site Reference ID/Investigator# 122696
Athens, Greece, 11527
Site Reference ID/Investigator# 55427
Athens, Greece, 11527
Site Reference ID/Investigator# 55429
Athens, Greece, 11527
Site Reference ID/Investigator# 122695
Athens, Greece, 15126
Site Reference ID/Investigator# 55428
Haidiari, Greece, 12462
Site Reference ID/Investigator# 55422
Ioanina, Greece, 45500
Site Reference ID/Investigator# 55425
Larissa, Greece, 411 10
Site Reference ID/Investigator# 55424
Thessaloniki, Greece, 57010
Site Reference ID/Investigator# 55423
Thessaloniki, Greece, 54642
Site Reference ID/Investigator# 122715
Thessaloniki, Greece, 56429
Site Reference ID/Investigator# 55426
Thessaloniki, Greece, 54636
Israel
Site Reference ID/Investigator# 75806
Haifa, Israel, 3109601
Site Reference ID/Investigator# 55564
Haifa, Israel, 31038
Site Reference ID/Investigator# 97335
Jerusalem, Israel, 91031
Site Reference ID/Investigator# 55568
Petach Tiqwa, Israel, 49100
Site Reference ID/Investigator# 55566
Tel Aviv, Israel, 64239
Site Reference ID/Investigator# 55569
Tel Hashomer, Israel, 5265601
Site Reference ID/Investigator# 55567
Zrifin, Israel, 70300
Mexico
Site Reference ID/Investigator# 55265
Chihuahua, Mexico, 31000
Site Reference ID/Investigator# 55267
Chihuahua, Mexico, 31000
Site Reference ID/Investigator# 55269
Guadalajara, Jalisco, Mexico, 44620
Site Reference ID/Investigator# 129043
Mexico City, Mexico, CP 03100
Site Reference ID/Investigator# 55268
Mexico City, Mexico, 04030
Site Reference ID/Investigator# 106595
Monterrey, NL, Mexico, 64600
Site Reference ID/Investigator# 76153
Monterrey, NL, Mexico, 64060
Netherlands
Site Reference ID/Investigator# 55283
Alkmaar, Netherlands, 1815 JD
Site Reference ID/Investigator# 55285
Gouda, Netherlands, 2803 HH
Site Reference ID/Investigator# 55287
Leeuwarden, Netherlands, 8934 AD
Site Reference ID/Investigator# 55284
Rotterdam, Netherlands, 3079 DZ
Portugal
Site Reference ID/Investigator# 55201
Coimbra, Portugal, 3000 - 075
Site Reference ID/Investigator# 55203
Lisbon, Portugal, 1169-050
Site Reference ID/Investigator# 55204
Lisbon, Portugal, 1050-034
Site Reference ID/Investigator# 128344
Ponte de Lima, Portugal, 4990-041
Site Reference ID/Investigator# 55199
Ponte de Lima, Portugal, 4990-041
Site Reference ID/Investigator# 55208
Porto, Portugal, 4099-001
Site Reference ID/Investigator# 55209
S. Martinho do Bispo (Coimbra), Portugal, 3041-801
Site Reference ID/Investigator# 55202
Viseu, Portugal, 3504-509
Puerto Rico
Site Reference ID/Investigator# 123075
Bayamon, Puerto Rico, 00961-7049
Site Reference ID/Investigator# 55487
Caguas, Puerto Rico, 00725
Site Reference ID/Investigator# 78453
Mayaguez, Puerto Rico, 00680
Site Reference ID/Investigator# 55485
Ponce, Puerto Rico, 00717-1321
Site Reference ID/Investigator# 54942
Vega Baja, Puerto Rico, 00693
Slovakia
Site Reference ID/Investigator# 55144
Banska Bystrica, Slovakia, 975 17
Site Reference ID/Investigator# 55150
Bratislava, Slovakia, 826 06
Site Reference ID/Investigator# 55147
Kosice, Slovakia, 040 11
Site Reference ID/Investigator# 55148
Kosice, Slovakia, 040 01
Site Reference ID/Investigator# 55145
Piestany, Slovakia, 92112
Site Reference ID/Investigator# 55146
Piestany, Slovakia, 922 12
Site Reference ID/Investigator# 55149
Piestany, Slovakia, 925 12
Site Reference ID/Investigator# 55152
Piestany, Slovakia, 928 12
Switzerland
Site Reference ID/Investigator# 65962
Chur, Switzerland, 7000
Site Reference ID/Investigator# 74855
Clarens - Montreux, Switzerland, 1815
Site Reference ID/Investigator# 74856
Lausanne, Switzerland, 1005
United Kingdom
Site Reference ID/Investigator# 55434
Barnsley, United Kingdom, S75 2EP
Site Reference ID/Investigator# 55438
Basingstoke, Hants, United Kingdom, RG24 9NA
Site Reference ID/Investigator# 61696
Bury St. Edmunds, Suffolk, United Kingdom, IP33 2QZ
Site Reference ID/Investigator# 55433
Cambridge, United Kingdom, CB2 0QQ
Site Reference ID/Investigator# 55435
Dewsbury, United Kingdom, WF13 4HS
Site Reference ID/Investigator# 55436
Glasgow, United Kingdom, G12 0YN
Site Reference ID/Investigator# 55431
Harrogate, United Kingdom, HG2 7SX
Site Reference ID/Investigator# 55514
Leicester, United Kingdom, LE1 5WW
Site Reference ID/Investigator# 119776
London, United Kingdom, NW3 2Qg
Site Reference ID/Investigator# 119777
Warrington, United Kingdom, WA5 1QG
Site Reference ID/Investigator# 57306
Westcliff on Sea, United Kingdom, SS0 0RY
Site Reference ID/Investigator# 119775
Wigan, United Kingdom, WN6 9EP
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: October 10, 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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014