PMID- 29780263
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231112
IS  - 1179-5441 (Print)
IS  - 1179-5441 (Electronic)
IS  - 1179-5441 (Linking)
VI  - 11
DP  - 2018
TI  - A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single 
      Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee.
PG  - 1179544118773068
LID - 10.1177/1179544118773068 [doi]
LID - 1179544118773068
AB  - BACKGROUND AND OBJECTIVE: To perform an integrated analysis of 2 randomized 
      controlled trials (RCTs) to assess the efficacy and safety of a single 
      intra-articular injection of Gel-200 compared with phosphate buffered saline 
      (PBS) for treatment of osteoarthritis of the knee. METHODS: Data from the 
      intention-to-treat (ITT) populations of both RCTs were pooled for this integrated 
      analysis. Mean changes from baseline in Western Ontario and McMaster Universities 
      Arthritis Index (WOMAC) pain subscores were assessed using a longitudinal model; 
      treatment differences were compared between intra-articular Gel-200 and PBS 
      injections. Analyses included secondary outcome measures repeated at individual 
      time points. The safety populations of both RCTs were pooled for an integrated 
      safety analysis to compare adverse events (AEs). RESULTS: The pooled ITT 
      population included 1184 subjects (649 Gel-200; 535 PBS); demographic 
      characteristics were similar between treatment groups. Mean improvements in pain 
      subscores from baseline to week 12 were -24.7 mm in Gel-200 and -21.8 mm in PBS 
      groups, a statistically significant treatment group difference of -2.9 mm (P = 
      .047). From weeks 3 to 26, mean improvements from baseline in pain subscores were 
      -23.8 mm with Gel-200 and -20.8 mm with PBS; this treatment group difference of 
      -3.0 mm was statistically significant (P = .017). The rate of AEs was similar 
      between Gel-200 and PBS treatment groups. CONCLUSION: This integrated analysis 
      demonstrated the efficacy of a single intra-articular injection of Gel-200 
      compared with PBS for treatment of osteoarthritis of the knee over 26 weeks 
      without major safety concerns. TRIAL REGISTRATION: NCT00449696 and NCT00450112.
FAU - Takamura, Junko
AU  - Takamura J
AD  - R&D Planning Department, Research & Development Division, Seikagaku Corporation, 
      Tokyo, Japan.
FAU - Seo, Takayuki
AU  - Seo T
AD  - Clinical Development Department, Research & Development Division, Seikagaku 
      Corporation, Tokyo, Japan.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Division of Immunology and Rheumatology, Stanford University School of Medicine, 
      Palo Alto, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00449696
SI  - ClinicalTrials.gov/NCT00450112
PT  - Journal Article
DEP - 20180509
PL  - United States
TA  - Clin Med Insights Arthritis Musculoskelet Disord
JT  - Clinical medicine insights. Arthritis and musculoskeletal disorders
JID - 101542737
PMC - PMC5952279
OTO - NOTNLM
OT  - Gel-200
OT  - Osteoarthritis
OT  - cross-linked HA
OT  - intra-articular
OT  - knee
COIS- Declaration Of Conflicting Interests:The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: J.T. and T.S. are employees of Seikagaku 
      Corporation. J.T. is listed as an inventor of a hyaluronate product. V.S. has 
      served as a consultant to Seikagaku Corporation as well as Bioventus, Carbylan, 
      Eupraxia, Flexion, Iroko, and Sanofi.
EDAT- 2018/05/22 06:00
MHDA- 2018/05/22 06:01
PMCR- 2018/05/09
CRDT- 2018/05/22 06:00
PHST- 2018/01/30 00:00 [received]
PHST- 2018/04/04 00:00 [accepted]
PHST- 2018/05/22 06:00 [entrez]
PHST- 2018/05/22 06:00 [pubmed]
PHST- 2018/05/22 06:01 [medline]
PHST- 2018/05/09 00:00 [pmc-release]
AID - 10.1177_1179544118773068 [pii]
AID - 10.1177/1179544118773068 [doi]
PST - epublish
SO  - Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. 
      doi: 10.1177/1179544118773068. eCollection 2018.