Osteoporosis, Rheumatoid Arthritis
Conditions
Keywords
Bone mineral density, Bone turnover markers, Rheumatoid arthritis, Osteoporosis
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | 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 Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 | 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 | 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 | 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 | 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 | 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 at Baseline, Month 3, Month 12, and Month 24 | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lack of Efficacy | 16 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Participant's Decision | 6 |
Baseline characteristics
| Characteristic | Participants With Active Rheumatoid Arthritis (RA) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 123 Participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 131 |
| serious Total, serious adverse events | 1 / 131 |
Outcome results
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.
Time frame: Baseline (Day 0), Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | L1-L4 BMD: Baseline; n=86 | 1.06 g/cm^2 | Standard Deviation 0.15 |
| Participants With Active Rheumatoid Arthritis (RA) | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | L1-L4 BMD: Month 12; n=71 | 1.07 g/cm^2 | Standard Deviation 0.17 |
| Participants With Active Rheumatoid Arthritis (RA) | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | L1-L4 BMD: Month 24; n=59 | 1.06 g/cm^2 | Standard Deviation 0.17 |
| Participants With Active Rheumatoid Arthritis (RA) | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | Proximal Femur BMD: Baseline; n=86 | 0.88 g/cm^2 | Standard Deviation 0.14 |
| Participants With Active Rheumatoid Arthritis (RA) | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | Proximal Femur BMD: Month 12; n=72 | 0.91 g/cm^2 | Standard Deviation 0.13 |
| Participants With Active Rheumatoid Arthritis (RA) | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | Proximal Femur BMD: Month 24; n=58 | 0.90 g/cm^2 | Standard Deviation 0.13 |
Primary
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
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 3; n=14 | -0.01 µg/L | Standard Deviation 0.09 |
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 12; n=14 | 0.06 µg/L | Standard Deviation 0.46 |
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 24; n=11 | -0.01 µg/L | Standard Deviation 0.28 |
Primary
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
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 3; n=8 | 8.70 ng/mL | Standard Deviation 17.78 |
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 12; n=11 | -1.87 ng/mL | Standard Deviation 17.22 |
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 24; n=7 | 15.29 ng/mL | Standard Deviation 21.18 |
Primary
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
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 3; n=6 | -2.97 µg/L | Standard Deviation 4.68 |
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 12; n=9 | -2.21 µg/L | Standard Deviation 11.99 |
| Participants With Active Rheumatoid Arthritis (RA) | Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 | Baseline - Month 24; n=5 | 1.39 µg/L | Standard Deviation 8.77 |
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.
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24 | Baseline; n=84 | 95.0 minutes | Standard Deviation 58.34 |
| Participants With Active Rheumatoid Arthritis (RA) | Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24 | Month 3; n=60 | 37.5 minutes | Standard Deviation 42.48 |
| Participants With Active Rheumatoid Arthritis (RA) | Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24 | Month 12; n=51 | 27.7 minutes | Standard Deviation 34.63 |
| Participants With Active Rheumatoid Arthritis (RA) | Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24 | Month 24; n=53 | 25.8 minutes | Standard Deviation 27.27 |
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.
Time frame: Baseline (Day 0), Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | L1-L4 T-score: Baseline; n=85 | -0.57 standard deviations | Standard Deviation 1.14 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | L1-L4 T-score: Month 12; n=71 | -0.42 standard deviations | Standard Deviation 1.15 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | L1-L4 T-score: Month 24; n=58 | -0.40 standard deviations | Standard Deviation 1.15 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | L1-L4 Z-score: Baseline; n=82 | -0.02 standard deviations | Standard Deviation 1.14 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | L1-L4 Z-score: Month 12; n=67 | 0.15 standard deviations | Standard Deviation 1.08 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | L1-L4 Z-score: Month 24; n=54 | 0.21 standard deviations | Standard Deviation 1.09 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | Proximal Femur T-score: Baseline; n=85 | -0.70 standard deviations | Standard Deviation 1.11 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | Proximal Femur T-score: Month 12; n=72 | -0.60 standard deviations | Standard Deviation 0.97 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | Proximal Femur T-score: Month 24; n=55 | -0.68 standard deviations | Standard Deviation 1.03 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | Proximal Femur Z-score: Baseline; n=82 | -0.18 standard deviations | Standard Deviation 1.05 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | Proximal Femur Z-score: Month 12; n=68 | -0.10 standard deviations | Standard Deviation 0.96 |
| Participants With Active Rheumatoid Arthritis (RA) | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 | Proximal Femur Z-score: Month 24; n=52 | -0.14 standard deviations | Standard Deviation 1.04 |
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).
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | Baseline; n=87 | 14.3 joints | Standard Deviation 6.52 |
| Participants With Active Rheumatoid Arthritis (RA) | Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | Month 3; n=87 | 3.1 joints | Standard Deviation 3.01 |
| Participants With Active Rheumatoid Arthritis (RA) | Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | Month 12; n=87 | 1.9 joints | Standard Deviation 2.39 |
| Participants With Active Rheumatoid Arthritis (RA) | Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | Month 24; n=84 | 1.7 joints | Standard Deviation 1.88 |
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.
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 | Baseline; n=87 | 6.24 units on a scale | Standard Deviation 0.73 |
| Participants With Active Rheumatoid Arthritis (RA) | Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 | Month 3; n=87 | 3.55 units on a scale | Standard Deviation 1.13 |
| Participants With Active Rheumatoid Arthritis (RA) | Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 | Month 12; n=85 | 2.86 units on a scale | Standard Deviation 1.04 |
| Participants With Active Rheumatoid Arthritis (RA) | Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 | Month 24; n=75 | 2.83 units on a scale | Standard Deviation 0.93 |
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.
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24 | Baseline; n=65 | 37.77 mm/1 hour | Standard Deviation 21.06 |
| Participants With Active Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24 | Month 3; n=64 | 17.97 mm/1 hour | Standard Deviation 14.91 |
| Participants With Active Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24 | Month 12; n=65 | 17.15 mm/1 hour | Standard Deviation 14.13 |
| Participants With Active Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24 | Month 24; n=63 | 17.67 mm/1 hour | Standard Deviation 12.34 |
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).
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | Baseline; n=87 | 9.5 joints | Standard Deviation 4.91 |
| Participants With Active Rheumatoid Arthritis (RA) | Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | Month 3; n=87 | 2.3 joints | Standard Deviation 2.76 |
| Participants With Active Rheumatoid Arthritis (RA) | Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | Month 12; n=87 | 1.0 joints | Standard Deviation 1.57 |
| Participants With Active Rheumatoid Arthritis (RA) | Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | Month 24; n=84 | 1.0 joints | Standard Deviation 1.22 |
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.
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Baseline | 68.0 units on a scale | Standard Deviation 11.77 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Month 3 | 29.7 units on a scale | Standard Deviation 16.69 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Month 12 | 23.0 units on a scale | Standard Deviation 15.5 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Month 24 | 21.5 units on a scale | Standard Deviation 13.45 |
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.
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24 | Baseline; n=86 | 71.3 units on a scale | Standard Deviation 12.38 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24 | Month 3; n=86 | 29.4 units on a scale | Standard Deviation 14.33 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24 | Month 12; n=85 | 25.8 units on a scale | Standard Deviation 16.56 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24 | Month 24; n=85 | 24.2 units on a scale | Standard Deviation 15.51 |
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.
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Baseline; n=86 | 71.1 units on a scale | Standard Deviation 12.36 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Month 3; n=86 | 31.4 units on a scale | Standard Deviation 16.18 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Month 12; n=85 | 24.7 units on a scale | Standard Deviation 15.18 |
| Participants With Active Rheumatoid Arthritis (RA) | Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 | Month 24; n=85 | 24.0 units on a scale | Standard Deviation 14.37 |