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A Belgian Registry of HUMIRA (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (ProAct)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Veeda Clinical Research, Brussels
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01078558
First received: March 1, 2010
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

This a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).


Condition Intervention
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
 Biological: adalimumab

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Five Year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing Spondylitis Who Are Treated With HUMIRA (Adalimumab)

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Swollen and tender joint count, C reactive protein, Erythrocyte sedimentation rate, Health assessment questionnaire, Body surface area with psoriasis, numerical rating scale, Bath ankylosing spondylitis disease activity index, concomitant medication [ Time Frame: 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months ] [ Designated as safety issue: No ]
  • Safety parameters/ SAE reporting [ Time Frame: 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5914
Study Start Date: May 2004
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with rheumatic disease
Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis
 Biological: adalimumab
subcutaneous administration for all patients
Other Name: HUMIRA

  Eligibility

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

Rheumatologists

Criteria

Inclusion Criteria:

  • Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
  • Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

  • Contraindications according to the summary of product characteristics.
  • Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078558

  Hide Study Locations
Locations
Belgium
Site Reference ID/Investigator# 4821
Aalst, Belgium, 9300
Site Reference ID/Investigator# 4791
Aalst, Belgium, 9300
Site Reference ID/Investigator# 28426
Aalst, Belgium, 9300
Site Reference ID/Investigator# 4811
Aalst, Belgium, 9300
Site Reference ID/Investigator# 28430
Amel, Belgium, 4770
Site Reference ID/Investigator# 4793
Antwerp, Belgium, 2018
Site Reference ID/Investigator# 4817
Antwerp, Belgium, 2018
Site Reference ID/Investigator# 4830
Antwerp, Belgium, 2020
Site Reference ID/Investigator# 4834
Arlon, Belgium, 6700
Site Reference ID/Investigator# 62675
Assebroek, Belgium, 8310
Site Reference ID/Investigator# 4837
Assebroek, Belgium, 8310
Site Reference ID/Investigator# 4848
Assebroek, Belgium, 8310
Site Reference ID/Investigator# 28454
Ath, Belgium, 7800
Site Reference ID/Investigator# 4773
Audregnies, Belgium, 7382
Site Reference ID/Investigator# 4828
Aye, Belgium, 6900
Site Reference ID/Investigator# 4856
Baudour, Belgium, 7331
Site Reference ID/Investigator# 4810
Belsele, Belgium, 9111
Site Reference ID/Investigator# 4832
Bonheiden, Belgium, 2820
Site Reference ID/Investigator# 28445
Bornem, Belgium, 2880
Site Reference ID/Investigator# 4842
Bruges, Belgium, 8000
Site Reference ID/Investigator# 62674
Brussels, Belgium, 1190
Site Reference ID/Investigator# 4769
Brussels, Belgium, 1000
Site Reference ID/Investigator# 28439
Brussels, Belgium, 1081
Site Reference ID/Investigator# 4815
Brussels, Belgium, 1190
Site Reference ID/Investigator# 28449
Brussels, Belgium, 1180
Site Reference ID/Investigator# 4766
Brussels, Belgium, 1150
Site Reference ID/Investigator# 28448
Brussels, Belgium, 1190
Site Reference ID/Investigator# 4797
Brussels, Belgium, 1200
Site Reference ID/Investigator# 4859
Brussels, Belgium, 1070
Site Reference ID/Investigator# 4860
Brussels, Belgium, 1070
Site Reference ID/Investigator# 4770
Brussels, Belgium, 1020
Site Reference ID/Investigator# 28405
Brussels, Belgium, 1020
Site Reference ID/Investigator# 28420
Brussels, Belgium, 1020
Site Reference ID/Investigator# 4863
Brussels, Belgium, 1090
Site Reference ID/Investigator# 28462
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 28416
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 28408
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 4767
Ciney, Belgium, 5590
Site Reference ID/Investigator# 28415
Courcelles, Belgium, 6180
Site Reference ID/Investigator# 28433
Destelbergen, Belgium, 9070
Site Reference ID/Investigator# 4772
Dinant, Belgium, 5500
Site Reference ID/Investigator# 4847
Edegem, Belgium, 2650
Site Reference ID/Investigator# 28421
Eeklo, Belgium, 9900
Site Reference ID/Investigator# 4798
Flemalle, Belgium, 4400
Site Reference ID/Investigator# 4831
Forchies-la-Marche, Belgium, 6141
Site Reference ID/Investigator# 4855
Genk, Belgium, 3600
Site Reference ID/Investigator# 4852
Genk, Belgium, 3600
Site Reference ID/Investigator# 4803
Genk, Belgium, 3600
Site Reference ID/Investigator# 4792
Genk, Belgium, 3600
Site Reference ID/Investigator# 4781
Genk, Belgium, 3600
Site Reference ID/Investigator# 28452
Genk, Belgium, 3600
Site Reference ID/Investigator# 28424
Gentbrugge, Belgium, 9050
Site Reference ID/Investigator# 4800
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4778
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4857
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4822
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4807
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4854
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4827
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4864
Ghent, Belgium, B-9000
Site Reference ID/Investigator# 28429
Ghent, Belgium, 9000
Site Reference ID/Investigator# 4838
Gistel, Belgium, 8470
Site Reference ID/Investigator# 4763
Gosselies, Belgium, 6041
Site Reference ID/Investigator# 4799
Gosselies, Belgium, 6041
Site Reference ID/Investigator# 28441
Halle, Belgium, 1500
Site Reference ID/Investigator# 4819
Hamme, Belgium, 9220
Site Reference ID/Investigator# 4775
Hasselt, Belgium, 3500
Site Reference ID/Investigator# 4777
Hasselt, Belgium, 3500
Site Reference ID/Investigator# 4802
Hasselt, Belgium, 3500
Site Reference ID/Investigator# 28428
Hoboken, Belgium, 2260
Site Reference ID/Investigator# 4836
Kalmthout, Belgium, 2920
Site Reference ID/Investigator# 4796
Keerbergen, Belgium, 3140
Site Reference ID/Investigator# 4780
Kortrijk, Belgium, 8500
Site Reference ID/Investigator# 28453
Kortrijk, Belgium, 8500
Site Reference ID/Investigator# 28463
Kortrijk, Belgium, 8500
Site Reference ID/Investigator# 4764
La Louviere, Belgium, 7100
Site Reference ID/Investigator# 4768
La Louviere, Belgium, 7100
Site Reference ID/Investigator# 28418
La Louviere, Belgium, 7100
Site Reference ID/Investigator# 4786
La Louviere, Belgium, 7100
Site Reference ID/Investigator# 4805
Lennik, Belgium, 1750
Site Reference ID/Investigator# 4814
Leuven, Belgium, 3000
Site Reference ID/Investigator# 4865
Leuven, Belgium, 3000
Site Reference ID/Investigator# 4809
Leuze-en-Hainaut, Belgium, 7900
Site Reference ID/Investigator# 4849
Libramont-Chevigny, Belgium, 6800
Site Reference ID/Investigator# 28407
Liege, Belgium, 4000
Site Reference ID/Investigator# 28425
Liege, Belgium, 4000
Site Reference ID/Investigator# 28419
Liege, Belgium, 4020
Site Reference ID/Investigator# 28423
Liege, Belgium, 4000
Site Reference ID/Investigator# 4841
Liege, Belgium, 4000
Site Reference ID/Investigator# 28451
Liege, Belgium, 4000
Site Reference ID/Investigator# 4782
Lier, Belgium, 2500
Site Reference ID/Investigator# 4795
Lobbes, Belgium, 6540
Site Reference ID/Investigator# 4779
Lokeren, Belgium, 9160
Site Reference ID/Investigator# 4808
Lommel, Belgium, 3920
Site Reference ID/Investigator# 4839
Malle, Belgium, 2390
Site Reference ID/Investigator# 28436
Marchienne-au-Pont, Belgium, 6030
Site Reference ID/Investigator# 4844
Mechelen, Belgium, 2800
Site Reference ID/Investigator# 4801
Mechelen, Belgium, 2800
Site Reference ID/Investigator# 4816
Merelbeke, Belgium, 9820
Site Reference ID/Investigator# 4790
Merksem, Belgium, 2170
Site Reference ID/Investigator# 4806
Merksem, Belgium, 2170
Site Reference ID/Investigator# 4840
Mons, Belgium, 7000
Site Reference ID/Investigator# 28440
Mons, Belgium, 7000
Site Reference ID/Investigator# 4804
Mons, Belgium, 7000
Site Reference ID/Investigator# 4820
Montegnee, Belgium, 4420
Site Reference ID/Investigator# 4812
Montignies sur Sambre, Belgium, 6061
Site Reference ID/Investigator# 4835
Montignies-sur-Sambre, Belgium, 6061
Site Reference ID/Investigator# 4776
Mouscron, Belgium, 7700
Site Reference ID/Investigator# 4846
Namur, Belgium, 5000
Site Reference ID/Investigator# 4788
Namur, Belgium, 5000
Site Reference ID/Investigator# 4818
Namur, Belgium, 5000
Site Reference ID/Investigator# 4861
Nazareth, Belgium, 9810
Site Reference ID/Investigator# 4765
Neupre Plainevaux, Belgium, 4122
Site Reference ID/Investigator# 4843
Neuville-en-Condroz, Belgium, 4121
Site Reference ID/Investigator# 4783
Ninove, Belgium, 9400
Site Reference ID/Investigator# 4789
Nukerke, Belgium, 9681
Site Reference ID/Investigator# 28432
Ostend, Belgium, 8400
Site Reference ID/Investigator# 4813
Ottignies, Belgium, 1340
Site Reference ID/Investigator# 4794
Plainevaux, Belgium, 4122
Site Reference ID/Investigator# 4850
Profondeville, Belgium, 5170
Site Reference ID/Investigator# 28464
Putte, Belgium, 2580
Site Reference ID/Investigator# 28443
Roeselare, Belgium, 8800
Site Reference ID/Investigator# 28442
Roeselare, Belgium, 8800
Site Reference ID/Investigator# 4845
Seraing, Belgium, 4100
Site Reference ID/Investigator# 46462
Sijsele, Belgium, 8340
Site Reference ID/Investigator# 4833
Sijsele, Belgium, 8340
Site Reference ID/Investigator# 4853
Sint-Niklaas, Belgium, 9100
Site Reference ID/Investigator# 4784
Sint-Niklaas, Belgium, 9100
Site Reference ID/Investigator# 28446
Tielt, Belgium, 8700
Site Reference ID/Investigator# 28447
Turnhout, Belgium, 2300
Site Reference ID/Investigator# 4774
Veldegem, Belgium, 8210
Site Reference ID/Investigator# 28437
Verviers, Belgium, 4800
Site Reference ID/Investigator# 4851
Verviers, Belgium, 4800
Site Reference ID/Investigator# 28427
Waremme, Belgium, 4300
Site Reference ID/Investigator# 4787
Wilrijk, Belgium, 2610
Site Reference ID/Investigator# 73526
Wilrijk, Belgium, 2610
Luxembourg
Site Reference ID/Investigator# 4879
Esch-sur-Alzette, Luxembourg, 4170
Site Reference ID/Investigator# 4881
Holzem, Luxembourg, 8277
Site Reference ID/Investigator# 4878
Luxembourg, Luxembourg, 1611
Site Reference ID/Investigator# 4880
Luxembourg, Luxembourg, 1361
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research, Brussels
Investigators
Study Director: Simonne Lens, MD AbbVie SA
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01078558     History of Changes
Other Study ID Numbers: HUM04-28
Study First Received: March 1, 2010
Last Updated: April 11, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by AbbVie:
Multicenter study

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
 Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013