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

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