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Efficacy and safety of a novel synergistic drug candidate - CRx-102 - in hand osteoarthritis
  1. T K Kvien (t.k.kvien{at}medisin.uio.no)
  1. Dept of Rheumatology, Diakonhjemmet Hospital, Oslo and Faculty of Medicine, University of Oslo, Norway
    1. E Fjeld (doktorfjeld{at}yahoo.no)
    1. Dept. of Rheumatology, Martina Hansens Hospital, Sandvika, Palau
      1. B Slatkowsky-Christensen (barbaras.christensen{at}diakonsyk.no)
      1. Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
        1. M Nichols (mnichols{at}combinatorx.com)
        1. CombinatoRx Inc., Cambridge, MA, United States
          1. Y Zhang (yzhang{at}combinatorx.com)
          1. CombinatoRx Inc., Cambridge, MA, United States
            1. A Prøven (anne.proven{at}mhh.no)
            1. Dept. of Rheumatology, Martina Hansens Hospital, Sandvika, Norway
              1. K Mikkelsen (knut.mikkelsen{at}revmatismesykehuset.no)
              1. Dept of Rheumatology, Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway
                1. Ø Palm (oyvind.palm{at}rikshospitalet.no)
                1. Dept. of Rheumatology, Østfold Hospital, Sarpsborg, Norway
                  1. A A Borisy (aborisy{at}combinatorx.com)
                  1. CombinatoRx Inc., Cambridge, MA, United States
                    1. J Lessem (jlessem{at}clinstrat.com)
                    1. CombinatoRx Inc., Cambridge, MA, United States

                      Abstract

                      Objective: The novel synergistic drug candidate CRx-102 comprises dipyridamole and low dose prednisolone and is in clinical development for the treatment of immuno-inflammatory 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, randomized, placebo-controlled trial at four centers in Norway. Eligibility criteria included age 30-70 years, at least one swollen and tender joint, a Kellgren-Lawrence (K-L) score of 2 or more on radiographs, and a score of at least 30 mm pain on the 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 HOA patients 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 hand OA and was generally well tolerated.

                      • CRx-102
                      • dipyridamole
                      • hand osteoarthritis
                      • prednisolone
                      • synergistic drug

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