Table 2.

Canakinumab studies in rheumatoid arthritis

Clinical phase	Study design	Results	NCT number; status
Phase 1/2 (ref. 27)	Patients (n = 53) with active RA under treatment with stable doses of methotrexate were randomized into four cohorts receiving 0.3, 1, 3 and 10 mg/kg canakinumab on days 5 and 15.	Clinical improvement was observed at week 6 in the 10 mg/kg treatment group, according to ACR20 criteria, with reduction of mean CRP values and normalization of its levels within a few days after treatment with 10 mg/kg canakinumab. Canakinumab administration to methotrexate-refractory patients resulted in clinical improvement.	NCT00619905; Completed
Phase 1/2	A four-arm study of canakinumab at doses of 10 mg/kg sc, 5 mg/kg iv, 2 mg/kg sc or 1 mg/kg iv, in 11 patients (18–75 years of age) with established RA.	The results of the study were not available as of September 2009.	NCT00505089; Terminated
Phase 1/2	A 12-week trial including 80 adult patients with RA. Patients were randomized into two groups receiving either placebo or canakinumab. The aim of the study is to investigate the biomarker profile of patients that respond to canakinumab treatment compared to those that do not.	The results of the study were not available as of September 2009.	NCT00504595; On-going, but not recruiting patients
Phase 2	A 12-week study designed to evaluate canakinumab risk-benefit profile in 273 patients with active RA receiving methotrexate (three groups with escalating sc dose regimens and one placebo group).	The results of the study were not available as of September 2009.	NCT00424346; Completed
Phase 2	A 76-week extension study of 208 patients with active RA who participated in the core NCT00424346 trial. Long-term safety and efficacy data according to the ACR20 criteria will be assessed during treatment with 300 mg canakinumab.	The results of the study were not available as of September 2009.	NCT00471198; Terminated
Phase 2	A 2-year study designed to evaluate the long-term safety, tolerability and efficacy of canakinumab in 160 patients with active RA.	The results of the study were not available as of September 2009.	NCT00784628; Terminated
Phase 2	A 54-week trial to assess the long-term safety and tolerability of canakinumab in 179 patients (18 to 75 years of age) with RA	The results of the study were not available as of September 2009.	NCT00554606; Recruiting
Phase 2/3	A 26-week, two arm study in 87 early RA patients receiving methotrexate. Patients (18 to 75 years of age) were randomized into two groups: iv canakinumab + methotrexate or placebo + methotrexate.	The results of the study were not available as of September 2009.	NCT00487825; On-going, but not recruiting patients

RA, rheumatoid arthritis; ACR20, American College of Rheumatology 20%; CRP, C-reactive protein.