A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
Phase: PHASE4
Conditions: Takayasu Arteritis, Tocilizumab, Adalimumab, Treatment
Sponsor: Shanghai Zhongshan Hospital

 
The Strategy of Prednisone Reduction  
For  
TACTIC-SS  - A Pilot Study in Severe Patients with Takayasu Arteritis. 
 
 
Clinical Trial No.:  NCT04300686 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Rheumatology 
Zhongshan Hospital, Fudan University 
Date: 2020-11-10 
 
 
 

1. All the enrolled patients in TACTIC-SS were prescribed the strategy prednisone and methotrexate, as well as the biological 
agents adalimumab or tocilizumab according to the randomized group.  
2. The dose of methotrexate is 15mg per week. The adalimumab is 40mg.q2weeks.IH, while the tocilizumab is 8mg/Kg. 
qm.IH.  
3. The dose of prednisone was adjusted according to the following schedule. 
4. The disease remission was defined as the disease status turning to inactivity. 
 
Background glucocorticoid treatment (Routine Protocol) 
 
 
Prior 
prednisone 
less than 40mg.qd 
(active status) 
Prior 
prednisone 
more 
than 
40mg.qd 
Prior 
prednisone 
less than 40mg.qd 
(inactive) 
or 
complicated with 
infection 
Notes 
months 
weeks  
 Dose 
Dose 
Dose  
 
0 
0 
40 
40 
30 
 
1 
2 
35 
35 
30 
 
1 
4 
30 
30 
25 
 
2 
6 
25 
25 
25  
 
2 
8 
20 
20 
25 
 
3 
12 
15 
15 
20 
 
4 
16 
10 
10 
15 
 
5 
20 
10 
10 
10 
 
6 
24 
10 
10 
10 
 
Biological agents switched if the disease remission was not achieved, and the prednisone would return 
to 40mg. 
 
7 
28 
10 
10 
10 
 
8 
32 
5 
5 
5 
 
9 
36 
5 
5 
5 
 
10 
40 
5 
5 
5 
 
11 
44 
5 
5 
5 
 
12 
48 
2.5 
2.5 
2.5 
 
Extended follow-up with prednisone free. If relapse occurred during follow-up, patients exited the 
investigation.  
 
13 
52 
2.5 
2.5 
2.5 
 
14 
56 
2.5 
2.5 
2.5 
 
15 
60 
0 
0 
0 
 
16 
64 
0 
0 
0 
 
17 
68 
0 
0 
0 
 
18 
72 
 
 
 
 
Notes: 
Prednisone adjustment for special conditions.  
1. If infection occurs (antibiotics needed), the prednisone would sustain the current dose and would not decrease till next 
month. Correspondingly, the biological agents would also suspend for a month as well.  
2. After the initial 6 months’ treatment, the biological agent strategy would be switched to the opposite if the disease 
remission could not be achieved, and the prednisone would return to 40mg as well.  
3. The target dose of prednisone is 0 mg at the 48-week. Subsequently, patients would be followed up with prednisone free 
for another 6 months. If relapse occurred during this period, patients would exit the study immediately.