Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Peking Union Medical College Hospital
With
Chengdu Yunke Pharmaceutical Co., Ltd.
This is a single-arm, open label, 24 weeks study. Patients with psoriatic arthritis get 99Tc-MDP 22mg (5.5mg/set, four sets) was injected intravenously once a day for 7 successive days, one course every 4 weeks until week 24.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18-70 years of age;
Clinical diagnosis of PsA according to the CASPAR classification criteria
Active PsA at baseline defined as ≥ 3 tender joints and ≥ 3 swollen joints
If subjects were taking csDMARDs, the doses of csDMARDs had to be stable for at least 4 weeks and had to remain the same during the trial
The application of bDMARDs and tsDMARDs should meet the following requirements:
1. Etanercept and its biological analogues: stop at least 4 weeks prior to their baseline visit;
2. Other biological: stop at least 6 months prior to their baseline visit
3. tsDMARDs: stop at least 8 weeks prior to their baseline visit
If subjects were taking glucocorticoids, the doses of GC(prednisone \< 10mg) had to be stable for at least 4 weeks and had to remain the same during the trial;
Non steroidal anti-inflammatory drugs: if applied, the dose was stable one week prior to their baseline visit
Negative pregnancy test for child-bearing women at screening and baseline
Provide written informed consent
You may not be if
Patients with severe heart, liver, kidney and other important organ diseases
Abnormal liver function (ALT or AST is 2 times higher than normal)
White blood cell count less than 4,000/mm\^3 (less than 4 X 10\^9/L)
Platelet count less than 100,000/mm\^3 (less than 100 X 10\^9/L)
Serum creatinine more than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L)
Pregnancy or breastfeeding women
Contraindications to 99Tc-MDP therapy and/or known hypersensitivity to 99Tc-MDP
Participated in other drugs clinical trials within 4 weeks
Clareo Health | A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
