Phase 3
Completed N=420
Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
Source: ClinicalTrials.gov NCT00647270 ↗Enrolled (actual)
420
Serious AEs
4.3%
Results posted
May 2010
Primary outcomePrimary: The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow) — 19; 80; 97; 37 participants — p=0.074
Summary
To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow) |
19; 80; 97; 37; 79; 108 | 0.074 |
| SECONDARY Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed) |
-0.11; -0.41; -0.39 | 0.002 sig |
| SECONDARY Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF]) |
-0.12; -0.40; -0.37 | 0.005 sig |
| SECONDARY Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed) |
0; -0.26; -0.24 | 0.002 sig |
| SECONDARY Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF]) |
0; -0.24; -0.21 | 0.005 sig |
Eligibility Criteria
Inclusion Criteria
- Subject > 18 years of age
- Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
- Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
- If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
- Subject is judged to be in generally good health as determined by the principal investigator
Exclusion Criteria
- Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
- Subject has a history of acute inflammatory joint disease of different origin other than RA
- Subject has been treated with any investigational biologic agents
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Data sourced from ClinicalTrials.gov (NCT00647270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.