A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Current formulation adalimumab 40 mg every other week
New formulation adalimumab 40 mg every other week
Site Reference ID/Investigator# 75073
Mesa, Arizona, United States
Serum Concentrations of Adalimumab at Weeks 12 and 24
Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.
Time frame: Measured at Weeks 12 and 24
Mean Disease Activity Scores (DAS28) at Weeks 12 and 24
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. 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.
Time frame: Measured at Weeks 12 and 24
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24
American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Time frame: Measured at Weeks 12 and 24
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24
American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
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Site Reference ID/Investigator# 75077
Hemet, California, United States
Site Reference ID/Investigator# 75076
Wichita, Kansas, United States
Site Reference ID/Investigator# 75075
Clifton, New Jersey, United States
Site Reference ID/Investigator# 83133
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 75074
Charleston, South Carolina, United States
Site Reference ID/Investigator# 75100
Brussels, Belgium
Site Reference ID/Investigator# 75101
Liège, Belgium
Site Reference ID/Investigator# 75104
Brno, Czechia
Site Reference ID/Investigator# 76788
Prague, Czechia
...and 11 more locations
Time frame: Measured at Weeks 12 and 24
Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire 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. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5.
Time frame: Measured at Weeks 12 and 24
Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24
The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.
Time frame: Measured at Weeks 12 and 24
Percentage of Participants Positive for Anti-adalimumab Antibody
Percentage of participants with anti-adalimumab antibody
Time frame: Measured through Week 24
Number of Participants With Adverse Events
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.
Time frame: From time of informed consent to 70 days following the last dose of study drug
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing "no pain" and 100 representing "worst possible pain". Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.
Time frame: Immediately after injections on Day 1