Rheumatoid Arthritis Clinical Trial
Official title:
Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)
NCT number | NCT01736189 |
Other study ID # | P13-684 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 11, 2012 |
Est. completion date | April 16, 2018 |
Verified date | June 2019 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This was a single-arm, multicenter, open label, prospective cohort study (post-marketing observational study) to determine the effectiveness and safety of adalimumab in combination with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a routine clinical setting in Japan.
Status | Completed |
Enrollment | 346 |
Est. completion date | April 16, 2018 |
Est. primary completion date | April 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 99 Years |
Eligibility |
Inclusion Criteria: The participants of this study were rheumatoid arthritis (RA) patients for whom adalimumab was prescribed. They must have met the following conditions: - Disease duration of RA =2 years - Methotrexate (MTX) administration =3 months prior to starting adalimumab - Dose of MTX =12mg/week - Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) score >3.2 Exclusion Criteria: - Participants who had been previously treated with biologics (including tumor necrosis factor [TNF] inhibitors and others) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52 | The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hr) or C-reactive protein (CRP; mg/dL) level, and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | At Week 52 | |
Secondary | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score = 2.8 at Week 104 | The Clinical Disease Activity Index (CDAI) is a composite index for assessing rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the participant's global assessment of disease activity (on a visual analog scale [VAS] from 0 to 10 cm), and a physician's global assessment of disease activity (measured on a VAS from 0 to 10 cm) are summed to yield the total score. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Remission is defined as a CDAI score = 2.8. | At Week 104 | |
Secondary | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score = 3.3 at Week 104 | The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score =26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score =3.3 indicates clinical remission. | At Week 104 | |
Secondary | Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported assessment specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined as HAQ-DI < 0.5. | At Week 104 | |
Secondary | Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104 | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. | Baseline and Week 104 | |
Secondary | Percentage of Participants With a Change From Baseline of = 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104 | The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at the visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. | Baseline and Week 104 |
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