title: Efficacy and safety of a novel synergistic drug candidate, CRx-102, in hand osteoarthritis.
abstract: OBJECTIVE
  The novel synergistic drug candidate CRx-102 comprises dipyridamole and low dose prednisolone and is in clinical development for the treatment of immunoinflammatory diseases. The purpose of this clinical study was to examine the efficacy and safety of CRx-102 in patients with hand osteoarthritis (HOA).
  
  
  METHODS
  The study was conducted as a blinded, randomised, placebo-controlled trial at four centres in Norway. Eligibility criteria included being of age 30-70 years, at least one swollen and tender joint, a Kellgren-Lawrence (K-L) score of 2 or higher on radiographs, and a score of at least 30 mm pain on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) visual analogue pain scale (VAS). The primary endpoint was a reduction in pain from baseline to day 42 on the AUSCAN pain subscale. Two-sided p values for the differences in least squares (LS) means adjusted for baseline are presented.
  
  
  RESULTS
  The mean age of the 83 patients with HOA was 60 years and 93% were females. CRx-102 was statistically superior to placebo at 42 days for changes in AUSCAN pain (LS mean -14.2 vs -4.0) and for clinically relevant secondary endpoints (joint pain VAS (-18.6 vs -6.3), patient global VAS (-15.9 vs -4.2)) in the intention to treat population. The most frequently reported adverse event during the study was headache (52% in CRx-102 vs 15% in the placebo group).
  
  
  CONCLUSIONS
  The novel synergistic drug candidate CRx-102 demonstrated efficacy by statistically reducing pain compared to placebo in HOA and was generally well tolerated.
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, N-0319 Oslo, Norway. t.k.kvien@medisin.uio.no
authors.forename: T K
authors.initials: TK
authors.lastname: Kvien
authors.forename: E
authors.initials: E
authors.lastname: Fjeld
authors.forename: B
authors.initials: B
authors.lastname: Slatkowsky-Christensen
authors.forename: M
authors.initials: M
authors.lastname: Nichols
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.forename: A
authors.initials: A
authors.lastname: Prøven
authors.forename: K
authors.initials: K
authors.lastname: Mikkelsen
authors.forename: Ø
authors.initials: Ø
authors.lastname: Palm
authors.forename: A A
authors.initials: AA
authors.lastname: Borisy
authors.forename: J
authors.initials: J
authors.lastname: Lessem
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004176:Dipyridamole / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D050823:Hand Joints; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy* / Q000473:pathology; D010147:Pain Measurement / Q000379:methods; D011239:Prednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; C530511:dipyridamole, prednisolone drug combination; D004176:Dipyridamole; D011239:Prednisolone