Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Masaryk University
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01078155
First received: February 26, 2010
Last updated: March 22, 2013
Last verified: March 2013
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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
Contacts
| Contact: Branislav Trutz, MD | +421 2 4445 4176 | branislav.trutz@abbvie.com |
| Contact: Maroš Lipták, MD | +421 2 4445 4188 | maros.liptak@abbvie.com |
Locations
| Czech Republic | |
| Site Reference ID/Investigator# 28346 | Active, not recruiting |
| Brno, Czech Republic, 65691 | |
| Site Reference ID/Investigator# 32406 | Active, not recruiting |
| Brno, Czech Republic, 639 00 | |
| Site Reference ID/Investigator# 32408 | Active, not recruiting |
| Brno, Czech Republic, 65691 | |
| Site Reference ID/Investigator# 32407 | Active, not recruiting |
| Brno, Czech Republic, 65691 | |
| Site Reference ID/Investigator# 28343 | Active, not recruiting |
| Bruntal, Czech Republic, 79201 | |
| Site Reference ID/Investigator# 47476 | Active, not recruiting |
| Chomutov, Czech Republic, 43012 | |
| Site Reference ID/Investigator# 48404 | Active, not recruiting |
| Hlucin, Czech Republic, 748 01 | |
| Site Reference ID/Investigator# 47471 | Active, not recruiting |
| Hradec Kralove, Czech Republic, 50005 | |
| Site Reference ID/Investigator# 28349 | Active, not recruiting |
| Jihlava, Czech Republic, 58601 | |
| Site Reference ID/Investigator# 57367 | Active, not recruiting |
| Kromeriz, Czech Republic, 76701 | |
| Site Reference ID/Investigator# 47478 | Active, not recruiting |
| Liberec, Czech Republic, 46001 | |
| Site Reference ID/Investigator# 47479 | Active, not recruiting |
| Liberec, Czech Republic, 46001 | |
| Site Reference ID/Investigator# 47477 | Active, not recruiting |
| Olomouc, Czech Republic, 77900 | |
| Site Reference ID/Investigator# 32409 | Active, not recruiting |
| Ostrava, Czech Republic, 72200 | |
| Site Reference ID/Investigator# 32405 | Active, not recruiting |
| Ostrava, Czech Republic, 708 52 | |
| Site Reference ID/Investigator# 28342 | Active, not recruiting |
| Ostrava, Czech Republic, 71700 | |
| Site Reference ID/Investigator# 28350 | Active, not recruiting |
| Ostrava, Czech Republic, 72200 | |
| Site Reference ID/Investigator# 47469 | Active, not recruiting |
| Pardubice, Czech Republic, 530 02 | |
| Site Reference ID/Investigator# 47473 | Active, not recruiting |
| Plzen, Czech Republic, 30529 | |
| Site Reference ID/Investigator# 47474 | Active, not recruiting |
| Plzen, Czech Republic, 30529 | |
| Site Reference ID/Investigator# 47472 | Active, not recruiting |
| Plzen, Czech Republic, 30529 | |
| Site Reference ID/Investigator# 47470 | Active, not recruiting |
| Prague, Czech Republic, 14000 | |
| Site Reference ID/Investigator# 32411 | Active, not recruiting |
| Prague 2, Czech Republic, 128 50 | |
| Site Reference ID/Investigator# 48403 | Active, not recruiting |
| Prague 2, Czech Republic, 128 50 | |
| Site Reference ID/Investigator# 48402 | Active, not recruiting |
| Prague 2, Czech Republic, 128 50 | |
| Site Reference ID/Investigator# 28354 | Active, not recruiting |
| Prague 2, Czech Republic, 12800 | |
| Site Reference ID/Investigator# 47475 | Active, not recruiting |
| Usti nad Labem, Czech Republic, 40011 | |
| Romania | |
| Site Reference ID/Investigator# 53850 | Active, not recruiting |
| Bucharest, Romania, 020475 | |
| Site Reference ID/Investigator# 53849 | Active, not recruiting |
| Bucharest, Romania, 020475 | |
| Site Reference ID/Investigator# 53862 | Recruiting |
| Iasi, Romania, 700661 | |
| Principal Investigator: Site Reference ID/Investigator# 53862 | |
| Site Reference ID/Investigator# 53865 | Recruiting |
| Targu-Mures, Romania, 540136 | |
| Principal Investigator: Site Reference ID/Investigator# 53865 | |
| Slovakia | |
| Site Reference ID/Investigator# 46084 | Active, not recruiting |
| Banska Bystrica, Slovakia, 975 17 | |
| Site Reference ID/Investigator# 46082 | Active, not recruiting |
| Bratislava, Slovakia, 826 06 | |
| Site Reference ID/Investigator# 46083 | Active, not recruiting |
| Kosice, Slovakia, 041 90 | |
| Site Reference ID/Investigator# 46085 | Active, not recruiting |
| 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: | March 22, 2013 |
| 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 May 19, 2013