Psoriatic arthritis |
Phase2 |
Doses Patients with PsA, who also had active plaque psoriasis were assigned to one of 2 groups: 1) 90 mg or 63 mg ustekinumab for the first 4 weeks, followed by placebo at weeks 12 and 16; 2) placebo for the first 4 weeks, followed by 63 mg ustekinumab at weeks 12 and 16. Patients were followed up until week 36. |
At week 12, 42% of the patients in Group 1 achieved an ACR20 score, compared with 14% in Group 2. 25% and 11 % of Group 1 patients achieved ACR50 and ACR70, respectively, compared with 5% and 0% in Group 2. 52% of ustekinumab treated group achieved PASI 75, compared with 5% in the placebo group. |
12 |
NCT00267 956 |
Crohn's Disease |
Phase2a |
Two populations of patients with a CDAI between 220–450 were enrolled. Population 1 had previously received conventional treatments. Patients were divided into 4 groups: 1) Weekly placebo between weeks 0–3, plus 90 mg ustekinumab (sc) between weeks 8–11; 2) Weekly ustekinumab (sc) between weeks 0–3, plus 90 mg placebo between weeks 8–11; 3) Placebo at week 0, then 4.5 mg/kg ustekinumab (iv) at week 8; 4) 4.5 mg/kg ustekinumab (iv) at week 0, then placebo at week 8. Population 2 consisted of non-responders to infliximab, who were given either 90 mg ustekinumab (sc) weekly between weeks 0–3 or 4.5 mg/kg ustekinumab (iv) at week 0. |
Population 1: At weeks 4 and 6, 53% of combined ustekinumab treated patients (Groups 2 and 4) were in clinical response, compared with 30% in the placebo treated patients (Groups 1 and 3). At week 8, the proportion of patients with a complete clinical response in the combined ustekinumab group was 49% compared with 40% in the placebo qroup. Population 2: At weeks 2 and 4, 22% and 41 % of patients in the combined ustekinumab group were in clinical response, the proportion reached 48% by week 6. At week 8, the clinical response rates were 43% for Group 1 and 54% for Group 2. |
14 |
NCT00265 122 |
|
Phase2/3 |
Patients with a history of anti-TNF therapy will be assigned to one of 4 groups receiving intravenous injections of 1 mg/kg, 3mg/kg or 6mg/kg ustekinumab (iv) or placebo at the start of the study. Ustekinumab-treated groups will be re-randomized to receive placebo or 90 mg ustekinumab (sc) at weeks 8 and 16. The placebo group will be re-randomized to receive placebo at weeks 8 and 16, or 270 mg ustekinumab (sc) at week 8 followed by 90 mg at week 16. Patients will be followed up until week 36. |
On-going (Currently recruiting participants) |
N/A |
NCT00771 667 |
Multiple Sclerosis |
Phase2 (Discontinued) |
Patients with relapsing-remitting MS were given 27, 90, 90q8w or 180 mg ustekinumab (sc) or placebo at weeks 0,1,2,3,7,11,15 and 19; 90q8w group received placebo at weeks 7 and 15. |
Ustekinumab was well tolerated, but was not effective in decreasing the cumulative number of newly formed Gd-enhancing T1-weighted lesions in MS. |
15 |
NCT00207 727 |