Clinical trial NCT01736189: Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Methotrexate
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 346
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with rheumatoid arthritis treated in a daily clinical setting, who received adalimumab (and high dose methotrexate \[≥12 mg/week\]), were observed prospectively.

Brief summary: 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.

Detailed description: Study assessments occurred at baseline, Week 12, Week 24, Week 52, Week 76, and Week 104. Most participants received 40 mg of adalimumab every other week during the study. Two participants started at 40 mg of adalimumab every other week, and increased to 80 mg every other week. A few participants had a different dose regimen: 40 mg every three weeks for 3 participants; 40 mg every four weeks for 1 participant; and 40 mg every other week with a switch to 50 mg every three weeks for 4 subjects.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score ≤ 2.8 at Week 104
timeFrame: At Week 104
measure: Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score ≤ 3.3 at Week 104
timeFrame: At Week 104
measure: Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104
timeFrame: At Week 104
measure: Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104
timeFrame: Baseline and Week 104
measure: Percentage of Participants With a Change From Baseline of ≤ 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104
timeFrame: Baseline and Week 104
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Mimori T, Yamanaka H, Sunaga N, Morita K, Kimura J, Takeuchi T. Effectiveness, safety, and methotrexate dose-tapering pattern over two years of treatment with adalimumab and >/=12 mg/week methotrexate for early rheumatoid arthritis: Results of the HAWK postmarketing surveillance study in Japan. Mod Rheumatol. 2020 May;30(3):424-433. doi: 10.1080/14397595.2019.1639931. Epub 2019 Jul 22.