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

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ClinicalTrials.gov Identifier: NCT01078155
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : May 29, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

February 26, 2010
March 2, 2010
May 12, 2015
May 29, 2015
June 26, 2015
March 2009
May 2014   (Final data collection date for primary outcome measure)
  • Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 12, Month 24 ]
    BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.
  • Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 12, Month 24 ]
    T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.
  • Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
  • Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
  • Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
  • Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    Participant-reported the existence and duration of morning stiffness, defined as "morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."
  • Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).
  • Bone densitometry (DEXA), [ Time Frame: Day 0, Month 12 ]
  • 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 24 ]
  • Morning stiffness [ Time Frame: Day 0,Month 3, Month 12, Month 24 ]
  • Tender Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ]
Complete list of historical versions of study NCT01078155 on ClinicalTrials.gov Archive Site
  • Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).
  • Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.
  • Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    Physician's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.
  • Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    Subject's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.
  • Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    Subject's Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.
  • Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24 [ Time Frame: Baseline (Day 0), Month 3, Month 12, Month 24 ]
    ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.
  • Swollen Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ]
  • DAS 28 (Assessment of Disease Activity) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ]
  • VAS (Visual Analogue Scale) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ]
  • ESR (Erythrocytes Sedimentation Rate) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ]
Not Provided
Not Provided
 
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
This post marketing observational study will be conducted in a prospective, single country, multicenter format to assess the prevention of generalized bone loss in patients with active rheumatoid arthritis (RA) treated with adalimumab (Humira®) in pragmatic prescribing situations. The investigational sites will be centers with experience in the treatment of RA patients and anti-tumor necrosis factor-alpha (TNF-a) therapy. The investigators will be rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological treatment.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
osteocalcin (OC), C-terminal type I procollagen peptide (CICP), C-telopeptide of type I collagen (CTX-I), whole blood (serum)
Non-Probability Sample
Patients with active rheumatoid arthritis
  • Rheumatoid Arthritis
  • Osteoporosis
Not Provided
Participants with Active Rheumatoid Arthritis (RA)
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
100
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with active early and long-standing RA according to American College of Rheumatology (ACR) 1987 revised criteria.
  • Patients with high disease activity DAS28 ≥ 5.1 according to the Czech Rheumatological Society criteria.
  • Patients must fulfill national guidelines for use of anti-TNF: inadequate clinical response to at least one disease-modifying antirheumatic drug (DMARD; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for Romania except glucocorticoids); chest X-ray, purified protein derivative (PPD)-skin test, Quantiferon/tuberculosis (TB) Gold test (if available) negative for TB.

Exclusion Criteria:

  • Patients who have had a history of TNF blocking or rituximab therapy.
  • Patients who are being treated or will be treated with drug at risk of interaction with adalimumab (Humira).
  • Pregnant females and/or females without adequate method of contraception.
  • Patients who didn't receive prior DMARD 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 Selective Estrogen Receptor Modulators (SERMs), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappaB ligand (RANKL) therapy.
  • Subjects who are not eligible for TNF-blocking therapy according to the Czech National Registry (ATTRA).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Czech Republic,   Romania,   Slovakia
 
NCT01078155
P10-733
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Maroš Lipták, MD Abbvie, Czech Republic & Slovakia
AbbVie
May 2015