Clinical trial NCT05000086: A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
Official title: A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Psoriatic
Keywords: 99Tc-MDP
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Chengdu Yunke Pharmaceutical Co., Ltd.
First posted: 2021-08-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Proportion of Patients Achieving DAS28-CRP<=3.2
timeFrame: 24 weeks
measure: Proportion of Patients Achieving DAS28-ESR<=3.2
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in PASI From Baseline From Baseline
timeFrame: 24 weeks
measure: Change in HAQ-DI Score From Baseline
timeFrame: 24 weeks
measure: ACR20
timeFrame: 12 weeks
measure: Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline
timeFrame: 24 weeks
measure: Percentage of Participants in MDA
timeFrame: 24 weeks
measure: Change in Tender Joint Count (TJC) 68 from baseline
timeFrame: 12 weeks and 24 weeks
measure: Change in Swollen Joint Count (SJC) 66 from baseline
timeFrame: 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College hospital
state: Dongcheng
Study officials:
References:
citation: Shen S, Wang W, Yang C, Xu B, Zeng L, Qian Y. Effect of technetium-99 conjugated with methylene diphosphonate (99 Tc-MDP) on OPG/RANKL/RANK system in vitro. J Oral Pathol Med. 2019 Feb;48(2):129-135. doi: 10.1111/jop.12801. Epub 2018 Dec 9.
citation: Mu R, Liang J, Sun L, Zhang Z, Liu X, Huang C, Zhu P, Zuo X, Gu J, Li X, Li X, Liu Y, Feng P, Li Z. A randomized multicenter clinical trial of 99 Tc-methylene diphosphonate in treatment of rheumatoid arthritis. Int J Rheum Dis. 2018 Jan;21(1):161-169. doi: 10.1111/1756-185X.12934. Epub 2017 Feb 3.
citation: Fu Q, Feng P, Sun LY, Zuo XX, Zhao DB, He DY, Wu HX, Zhang W, Zhang W, Du F, Bao CD. A double-blind, double-dummy, randomized controlled, multicenter trial of 99Tc-methylene diphosphonate in patients with moderate to severe rheumatoid arthritis. Chin Med J (Engl). 2021 May 19;134(12):1457-1464. doi: 10.1097/CM9.0000000000001527.
citation: Su D, Shen M, Gu B, Wang X, Wang D, Li X, Sun L. (99) Tc-methylene diphosphonate improves rheumatoid arthritis disease activity by increasing the frequency of peripheral gammadelta T cells and CD4(+) CD25(+) Foxp3(+) Tregs. Int J Rheum Dis. 2016 Jun;19(6):586-93. doi: 10.1111/1756-185X.12292. Epub 2014 Jan 28.