Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00870467 | A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis | PHASE3 | COMPLETED | 334 | — | — | Mar 1, 2009 | Aug 1, 2011 | Aug 7, 2012 | 88 | Japan |
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving 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.
| Arm | Type | Description |
|---|---|---|
| DB Placebo | PLACEBO_COMPARATOR | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB adalimumab | EXPERIMENTAL | Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Adalimumab/OL Adalimumab | EXPERIMENTAL | Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Placebo/OL Adalimumab | EXPERIMENTAL | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Adalimumab/RE OL Adalimumab | EXPERIMENTAL | Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Placebo/RE OL Adalimumab | EXPERIMENTAL | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| Name | Type | Description |
|---|---|---|
| Double-blind adalimumab | BIOLOGICAL | Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) |
| Double-blind Placebo | DRUG | Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow) |
| Open-label Adalimumab | BIOLOGICAL | Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study |
| Open-labelAdalimumabRescue | BIOLOGICAL | Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26 |
Inclusion Criteria * Rheumatoid arthritis based on the American College of Rheumatology criteria * Methotrexate or leflunomide naïve * Disease duration less than or equal to 2 years from diagnosis Exclusion Criteria * History of acute inflammatory joint disease of different origin from rheumatoid...