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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 4

Conditions: Arthritis, Psoriatic

Treatments: Drug: 99Tc methylene diphosphonate

Study type: Interventional

Funder types: Other

Identifiers

NCT05000086

YK1901PsA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

99Tc methylene diphosphonate

Experimental group

Description:

99Tc-MDP was applied as follows: for each course of treatment, 99Tc-MDP 22 mg (5.5mg/set, four sets) was injected intravenously once a day for 7 successive days, one course every 4 weeks until week 24.

Treatment:

Drug: 99Tc methylene diphosphonate