Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines. | Baseline (Day 0), Month 12, Month 24 |
| Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and 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. | Baseline (Day 0), Month 12, Month 24 |
| Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 | 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 | 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 | Baseline (Day 0), Month 3, Month 12, Month 24 | |
| Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined). | Baseline (Day 0), Month 3, Month 12, Month 24 |
| Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with active rheumatoid arthritis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maroš Lipták, MD | Abbvie, Czech Republic & Slovakia | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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-tumor necrosis factor (TNF) was taken prior to a participant's enrollment in the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
osteocalcin (OC), C-terminal type I procollagen peptide (CICP), C-telopeptide of type I collagen (CTX-I), whole blood (serum)
| Baseline (Day 0), Month 3, Month 12, Month 24 |
| Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | The investigator counted the number of tender joints at each study visit (28 joints are routinely examined). | 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. |
| Baseline (Day 0), Month 3, Month 12, Month 24 |
| Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 |
| Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 |
| Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 |
| Erythrocyte Sedimentation Rate (ESR) at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines. | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | g/cm^2 | Baseline (Day 0), Month 12, Month 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and 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. | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | standard deviations | Baseline (Day 0), Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 | Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point. | Posted | Mean | Standard Deviation | µg/L | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 | Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined). | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | joints | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score in 28 Joints (DAS28) at Baseline, 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. | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, 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. | Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 | Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point. | Posted | Mean | Standard Deviation | µg/L | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and 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." | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | minutes | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | The investigator counted the number of tender joints at each study visit (28 joints are routinely examined). | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | joints | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, 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. | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, 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. | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Erythrocyte Sedimentation Rate (ESR) at Baseline, 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. | Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point. | Posted | Mean | Standard Deviation | mm/1 hour | Baseline (Day 0), Month 3, Month 12, Month 24 |
|
|
268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 131 | 11 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis Allergic | Immune system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cutaneous Vasculitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Proximal Femur BMD: Baseline; n=86 |
|
| Proximal Femur BMD: Month 12; n=72 |
|
| Proximal Femur BMD: Month 24; n=58 |
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|