Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.
Detailed description
This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.
Exclusion criteria
* Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score (DAS28) | Weeks 0, 26, and 52 | The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Matrix Metalloprotease-3 (MMP-3) | Weeks 0, 26, and 52 | MMP-3 level in serum. Positive = \>/= 121.0 ng/mL (male) and 59.7 ng/mL (female) |
| Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 | Week 0 to Week 52 | Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Sum of scores was given as total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Weeks 0, 26, and 52 | Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement. |
| Number of Participants With Adverse Events (AEs) | Week 0 to Week 52 | Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) | 106 |
| Non-Adalimumab Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859) | 114 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 0 |
| Overall Study | Economic reasons | 6 | 0 |
| Overall Study | Initiation of biological therapy | 0 | 15 |
| Overall Study | Lack of Efficacy | 9 | 0 |
| Overall Study | No further visits | 5 | 7 |
| Overall Study | Refusal to receive adalimumab | 7 | 0 |
| Overall Study | Sufficient response to adalimumab | 8 | 0 |
Baseline characteristics
| Characteristic | Non-Adalimumab | Total | Adalimumab |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 12.3 | 55.3 years STANDARD_DEVIATION 12.6 | 56.0 years STANDARD_DEVIATION 13 |
| Body weight | 57.53 kg STANDARD_DEVIATION 11.08 | 56.53 kg STANDARD_DEVIATION 10.16 | 55.46 kg STANDARD_DEVIATION 8.99 |
| Concomitant Glucocorticoid Use No | 84 participants | 157 participants | 73 participants |
| Concomitant Glucocorticoid Use Yes | 30 participants | 63 participants | 33 participants |
| Disease Activity Score | 2.74 units on a scale STANDARD_DEVIATION 1.11 | 2.81 units on a scale STANDARD_DEVIATION 1.11 | 2.89 units on a scale STANDARD_DEVIATION 1.1 |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | 0.25 units on a scale STANDARD_DEVIATION 0.33 | 0.27 units on a scale STANDARD_DEVIATION 0.34 | 0.29 units on a scale STANDARD_DEVIATION 0.34 |
| Matrix Metalloprotease (MMP-3) Female | 88.88 ng/mL STANDARD_DEVIATION 182.09 | 87.94 ng/mL STANDARD_DEVIATION 152.09 | 86.94 ng/mL STANDARD_DEVIATION 113.09 |
| Matrix Metalloprotease (MMP-3) Male | 113.70 ng/mL STANDARD_DEVIATION 135.15 | 130.50 ng/mL STANDARD_DEVIATION 125.92 | 149.95 ng/mL STANDARD_DEVIATION 114.81 |
| Modified Total Sharp Score (mTSS) | 16.47 units on a scale STANDARD_DEVIATION 22.3 | 16.05 units on a scale STANDARD_DEVIATION 22.2 | 15.61 units on a scale STANDARD_DEVIATION 22.19 |
| Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate) No | 63 participants | 111 participants | 48 participants |
| Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate) Yes | 51 participants | 109 participants | 58 participants |
| Rheumatoid arthritis duration | 1.316 years STANDARD_DEVIATION 0.438 | 1.303 years STANDARD_DEVIATION 0.433 | 1.290 years STANDARD_DEVIATION 0.428 |
| Rheumatoid Factor Negative | 43 participants | 89 participants | 46 participants |
| Rheumatoid Factor Positive | 71 participants | 131 participants | 60 participants |
| Sex: Female, Male Female | 92 Participants | 179 Participants | 87 Participants |
| Sex: Female, Male Male | 22 Participants | 41 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 106 | 36 / 114 |
| serious Total, serious adverse events | 5 / 106 | 3 / 114 |
Outcome results
Primary
Disease Activity Score (DAS28)
The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Time frame: Weeks 0, 26, and 52
Population: All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Disease Activity Score (DAS28) | Week 0 | 2.93 units on a scale | Standard Deviation 1.05 |
| Adalimumab | Disease Activity Score (DAS28) | Week 26 | 2.72 units on a scale | Standard Deviation 1.12 |
| Adalimumab | Disease Activity Score (DAS28) | Week 52 | 2.70 units on a scale | Standard Deviation 1.08 |
| Non-Adalimumab | Disease Activity Score (DAS28) | Week 0 | 2.73 units on a scale | Standard Deviation 1.04 |
| Non-Adalimumab | Disease Activity Score (DAS28) | Week 26 | 3.17 units on a scale | Standard Deviation 1.11 |
| Non-Adalimumab | Disease Activity Score (DAS28) | Week 52 | 3.20 units on a scale | Standard Deviation 1.24 |
Comparison: Week 0p-value: 0.144Wilcoxon Rank Sum
Comparison: Week 26p-value: 0.004Wilcoxon Rank Sum
Comparison: Week 52p-value: 0.006Wilcoxon Rank Sum
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI)
Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
Time frame: Weeks 0, 26, and 52
Population: All participants with post-baseline HAQ-DI data, using LOCF imputation method
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 26 | 0.20 units on a scale | Standard Deviation 0.32 |
| Adalimumab | Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 52 | 0.20 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 0 | 0.27 units on a scale | Standard Deviation 0.32 |
| Non-Adalimumab | Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 26 | 0.24 units on a scale | Standard Deviation 0.36 |
| Non-Adalimumab | Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 52 | 0.26 units on a scale | Standard Deviation 0.39 |
| Non-Adalimumab | Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 0 | 0.24 units on a scale | Standard Deviation 0.33 |
Comparison: Week 0p-value: 0.266Wilcoxon Rank Sum
Comparison: Week 26p-value: 0.44Wilcoxon Rank Sum
Comparison: Week 52p-value: 0.609Wilcoxon Rank Sum
Secondary
Matrix Metalloprotease-3 (MMP-3)
MMP-3 level in serum. Positive = \>/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
Time frame: Weeks 0, 26, and 52
Population: All participants with post-baseline MMP-3 data, using LOCF imputation method
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 52 Negative | 72 units on a scale |
| Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 0 Negative | 57 units on a scale |
| Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 26 Positive | 34 units on a scale |
| Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 26 Negative | 59 units on a scale |
| Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 52 Positive | 21 units on a scale |
| Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 0 Positive | 36 units on a scale |
| Non-Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 52 Negative | 53 units on a scale |
| Non-Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 0 Positive | 30 units on a scale |
| Non-Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 26 Negative | 61 units on a scale |
| Non-Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 0 Negative | 66 units on a scale |
| Non-Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 52 Positive | 43 units on a scale |
| Non-Adalimumab | Matrix Metalloprotease-3 (MMP-3) | Week 26 Positive | 35 units on a scale |
Comparison: Week 0p-value: 0.29Fisher Exact
Comparison: Week 26p-value: 1Fisher Exact
Comparison: Week 52p-value: 0.001Fisher Exact
Secondary
Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Sum of scores was given as total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Time frame: Week 0 to Week 52
Population: All participants with post-baseline mTSS data, using LOCF imputation method
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 | 0.8 units on a scale | Standard Deviation 3.9 |
| Non-Adalimumab | Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 | 0.6 units on a scale | Standard Deviation 1.8 |
p-value: 0.335Wilcoxon Rank Sum
Secondary
Number of Participants With Adverse Events (AEs)
Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
Time frame: Week 0 to Week 52
Population: All participants registered
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Number of Participants With Adverse Events (AEs) | 51 participants |
| Non-Adalimumab | Number of Participants With Adverse Events (AEs) | 39 participants |