Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Masaryk University
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01078155
First received: February 26, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

Tumor Necrosis Factor blocking therapy with adalimumab can modulate bone turnover markers as well as bone mineral density in cohort of patients with active Rheumatoid Arthritis. The endpoint of prevention of generalized bone loss in patients with active Rheumatoid Arthritis treated with Humira in pragmatic prescribing situations. This Post Marketing Observational Study will be conducted in a prospective, double-arm, single-country, multicenter format. The investigational sites will be centers with experience in the treatment of Rheumatoid Arthritis patients and the anti TNF-a therapy. The investigators will be rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological treatment. Since this will be a Post Marketing Observational Study, Humira® will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as the local guidelines.


Condition
Rheumatoid Arthritis
Osteoporosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Bone densitometry (DEXA), [ Time Frame: Day 0, Month 12. Month 24 ] [ Designated as safety issue: No ]
  • Bone turnover markers (osteocalcin - OC, C-terminal type I procollagen peptide - CICP, and C-telopeptide of type I collagen - CTX-I) [ Time Frame: Day 0, Month 3, Month 12 ] [ Designated as safety issue: No ]
  • Morning stiffness [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
  • Tender Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Swollen Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
  • DAS 28 (Assessment of Disease Activity) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
  • VAS (Visual Analogue Scale) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
  • ESR (Erythrocytes Sedimentation Rate) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

osteocalcine (OC), C-terminal type I procollagen peptide (CICP), C-telopeptide of type I collagen (CTX-I), whole blood (serum)


Estimated Enrollment: 305
Study Start Date: March 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with active Rheumatoid Arthritis
Patients (women and men) with active early and long-standing Rheumatoid Arthritis according to American College of Rheumatology revised criteria from 1987.

Detailed Description:

Follow-up of patients enables 4 patient visits during this period. Screening/Inclusion Visit is performed when the decision to start anti Tumor Necrosis Factor-alfa therapy is made. Inclusion of patient will succeed at day 0 (Screening/Inclusion Visit). The Second Visit follows 3 month after the Screening/Inclusion Visit. The Third and Fourth Visits are taking place at the month 12 and month 24 of the patient treatment. For these reasons, the most likely visits are defined as "S/V", "V1", "V2", "V3". The end point is an evidence of prevention of generalized bone loss in patients with active Rheumatoid Arthritis treated with Humira® in pragmatic prescribing situations.

  Eligibility

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

Patients with active rheumatoid arthritis

Criteria

Inclusion Criteria:

  • Patients with active early and long-standing RA (rheumatoid arthritis) according to ACR (American College of Rheumatology) 1987 revised criteria.
  • Patients with high disease activity {DAS28 (Assessment of Disease Activity) >5.1 according to the Czech Rheumatological Society criteria}.
  • Patients must fulfill national guidelines for use of anti-Tumor Necrosis Factor:

    • inadequate clinical response to at least one DMARD (methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to at least 5 mg prednisolone per day),
    • Chest X-ray, PPD-skin test, Quantiferon/TB Gold test if available negative for tuberculosis).

Exclusion Criteria:

  • Patients who have had a history of Tumor Necrosis Factor blocking or rituximab therapy.
  • Patients who are being treated or will be treated with drug at risk of interaction with Humira ®.
  • Pregnant female and/or female without adequate method of contraception. Patients who didn't receive prior DMARD (Disease-modifying antirheumatic drugs) therapy.
  • Patients participating in another study or clinical trial.
  • Patients with severe osteoporosis {T-score (number that indicates whether or not bone loss has occurred) of ≤ -2.5 and/or prior vertebral fracture/s/}.
  • Patients with a history of total hip replacement of both extremities.
  • Patients who currently receive and/or received bone metabolism modulating agents including SERMs (Selective Estrogen Receptor Modulators), bisphosphonates, parathyroid hormone or anti-RANKL (receptor activator of nuclear factor-kappaB ligand) therapy.
  • Subjects who are not eligible for TNF - blocking therapy according to the Czech National Registry ( ATTRA).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078155

Locations
Czech Republic
Site Reference ID/Investigator# 32406
Brno, Czech Republic, 639 00
Site Reference ID/Investigator# 32408
Brno, Czech Republic, 65691
Site Reference ID/Investigator# 28346
Brno, Czech Republic, 65691
Site Reference ID/Investigator# 32407
Brno, Czech Republic, 65691
Site Reference ID/Investigator# 28343
Bruntal, Czech Republic, 79201
Site Reference ID/Investigator# 47476
Chomutov, Czech Republic, 43012
Site Reference ID/Investigator# 48404
Hlucin, Czech Republic, 748 01
Site Reference ID/Investigator# 47471
Hradec Kralove, Czech Republic, 50005
Site Reference ID/Investigator# 28349
Jihlava, Czech Republic, 58601
Site Reference ID/Investigator# 57367
Kromeriz, Czech Republic, 76701
Site Reference ID/Investigator# 47479
Liberec, Czech Republic, 46001
Site Reference ID/Investigator# 47478
Liberec, Czech Republic, 46001
Site Reference ID/Investigator# 47477
Olomouc, Czech Republic, 77900
Site Reference ID/Investigator# 32405
Ostrava, Czech Republic, 708 52
Site Reference ID/Investigator# 28342
Ostrava, Czech Republic, 71700
Site Reference ID/Investigator# 28350
Ostrava, Czech Republic, 72200
Site Reference ID/Investigator# 32409
Ostrava, Czech Republic, 72200
Site Reference ID/Investigator# 47469
Pardubice, Czech Republic, 530 02
Site Reference ID/Investigator# 47474
Plzen, Czech Republic, 30100
Site Reference ID/Investigator# 47472
Plzen, Czech Republic, 30100
Site Reference ID/Investigator# 47473
Plzen, Czech Republic, 30100
Site Reference ID/Investigator# 47470
Prague, Czech Republic, 14000
Site Reference ID/Investigator# 32411
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 28354
Prague 2, Czech Republic, 12800
Site Reference ID/Investigator# 48403
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 48402
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 47475
Usti nad Labem, Czech Republic, 40011
Romania
Site Reference ID/Investigator# 53849
Bucharest, Romania, 020475
Site Reference ID/Investigator# 53850
Bucharest, Romania, 020475
Site Reference ID/Investigator# 53862
Iasi, Romania, 700661
Site Reference ID/Investigator# 53865
Targu-Mures, Romania, 540136
Slovakia
Site Reference ID/Investigator# 46084
Banska Bystrica, Slovakia, 975 17
Site Reference ID/Investigator# 46082
Bratislava, Slovakia, 826 06
Site Reference ID/Investigator# 46083
Kosice, Slovakia, 041 90
Site Reference ID/Investigator# 46085
Piestany, Slovakia, 921 12
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Masaryk University
Investigators
Principal Investigator: Ladislav Senolt, MD Rheumatological Institute, Prague, Czech republic
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01078155     History of Changes
Other Study ID Numbers: P10-733
Study First Received: February 26, 2010
Last Updated: April 10, 2014
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Slovak Republic: Ethics Committee

Keywords provided by AbbVie:
Bone mineral density
Bone turnover markers
Rheumatoid arthritis
Osteoporosis

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

ClinicalTrials.gov processed this record on April 16, 2014