Document Detail

A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis.
MedLine Citation:
PMID:  18576295     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX). METHODS: We conducted a prospective, 24-week, followup, multicenter, double-blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment. RESULTS: A total of 236 RA patients were included; 211 patients (89.4%) completed the 24-week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C-reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05). CONCLUSION: CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.
Ling-Ling Zhang; Wei Wei; Feng Xiao; Jian-Hua Xu; Chun-De Bao; Li-Qing Ni; Xing-Fu Li
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  59     ISSN:  0004-3591     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2008 Jul 
Date Detail:
Created Date:  2008-07-15     Completed Date:  2008-08-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  905-10     Citation Subset:  AIM; IM    
Anhui Medical University, Key Laboratory of Antiinflammatory and Immunopharmacology in Anhui Province, Hefei, China.
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MeSH Terms
Antirheumatic Agents / adverse effects,  therapeutic use*
Arthritis, Rheumatoid / drug therapy*
Collagen Type II / adverse effects,  therapeutic use*
Double-Blind Method
Methotrexate / adverse effects,  therapeutic use*
Middle Aged
Treatment Outcome
Reg. No./Substance:
0/Antirheumatic Agents; 0/Collagen Type II; 59-05-2/Methotrexate

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