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Open-labelAdalimumabRescue · 1 trial · 1 indication
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...
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Open-labelAdalimumabRescue is a monoclonal antibody being studied for the treatment of rheumatoid arthritis. It is currently in Phase 3 clinical development and is being developed by Abbott Laboratories. The drug is intended for use in patients with this autoimmune condition, which causes joint inflammation and pain.
Open-labelAdalimumabRescue is a monoclonal antibody that targets tumor necrosis factor, a key driver of inflammation in rheumatoid arthritis. By neutralizing this cytokine, the drug aims to reduce the inflammatory response and alleviate symptoms associated with the disease.
Open-labelAdalimumabRescue is being developed by Abbott Laboratories, a global healthcare company traded on the New York Stock Exchange under the ticker symbol ABT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with rheumatoid arthritis.
Open-labelAdalimumabRescue is in Phase 3 clinical development for rheumatoid arthritis. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Open-labelAdalimumabRescue has one completed Phase 3 clinical trial, identified as NCT00870467, titled 'A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis.' This randomized, double-blind, placebo-controlled study enrolled 334 participants in Japan and has been completed.
Open-labelAdalimumabRescue is a formulation of adalimumab, a well-known anti-TNF monoclonal antibody. The name indicates an open-label rescue treatment approach, but the active ingredient is adalimumab, which is used in rheumatoid arthritis and other inflammatory conditions.