A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis

• Status: Completed
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is aim to evaluate the efficacy and safety of technetium [99Tc] methylene diphosphonate (99Tc-MDP, trade name: Yunke) in the treatment of psoriatic arthritis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Chengdu Yunke Pharmaceutical Co., Ltd.
• Treatments: Diphosphonates; Methylene diphosphonate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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