Research article
A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis
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* Corresponding author: Wei Wei wwei@ahmu.edu.cn
1 Institute of Clinical Pharmacology, Anhui Medical University, Key Laboratory of Anti-inflammatory and Immunopharmacology of Education Ministry, 81 Meishan Road, Hefei 230032, PR China
2 Rheumatism and Immunity Department, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei 230022, PR China
3 Rheumatism and Immunity Department, The Affiliated Shanghai Renji Hospital of Shanghai Jiao Tong University, 1630 Dongfang Road, Shanghai 200127, PR China
4 Rheumatism and Immunity Department, Shanghai Guanghua Hospital, 540 Xinhua Road, Shanghai 200052, PR China
5 Rheumatism and Immunity Department, Qilu Hospital of Shandong University, 107 Wenhua Road, Jinan 250012, PR China
6 Rheumatism and Immunity Department, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou 510630, PR China
7 Rheumatism and Immunity Department, The Affiliated Drum Tower Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing 210008, PR China
8 Rheumatism and Immunity Department, Southwest Hospital of Third Military Surgeon University, 30 Shapingba Gaotanyan Street, Chongqing 400038, PR China
9 Rheumatism and Immunity Department, The Affiliated Hospital of Taishan Medical College, 706 Tanshan Street, Taian 271000, PR China
Arthritis Research & Therapy 2009, 11:R180 doi:10.1186/ar2870
Published: 1 December 2009Abstract
Introduction
Chicken type II collagen (CCII) is a protein extracted from the cartilage of chicken breast and exhibits intriguing possibilities for the treatment of autoimmune diseases by inducing oral tolerance. A 24-week, double-blind, double-dummy, randomized, methotrexate (MTX)-controlled study was conducted to evaluate the efficacy and safety of CCII in the treatment of rheumatoid arthritis (RA).
Methods
Five hundred three RA patients were included in the study. Patients received either 0.1 mg daily of CCII (n = 326) or 10 mg once a week of MTX (n = 177) for 24 weeks. Each patient was evaluated for pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), assessments by investigator and patient, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) by using the standard tools at baseline (week 0) and at weeks 12 and 24. Additionally, rheumatoid factor (RF) was evaluated at weeks 0 and 24. Measurement of a battery of biochemical parameters in serum, hematological parameters, and urine analysis was performed to evaluate the safety of CCII.
Results
Four hundred fifty-four patients (94.43%) completed the 24-week follow-up. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, HAQ, and assessments by investigator and patient, and all differences were statistically significant. In the MTX group, ESR and CRP decreased. RF did not change in either group. At 24 weeks, 41.55% of patients in the CCII group and 57.86% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR-20) and 16.89% and 30.82%, respectively, met the ACR 50% improvement criteria (ACR-50). Both response rates for ACR-20 and ACR-50 in the CCII group were lower than those of the MTX group, and this difference was statistically significant (P < 0.05). The DAS28 (disease activity score using 28 joint counts) values of the two treatment groups were calculated, and there was a statistically significant difference between the two treatment groups (P < 0.05). Gastrointestinal complaints were common in both groups, but there were fewer and milder side effects in the CCII group than in the MTX group. The incidence of adverse events between the two groups was statistically significant (P < 0.05).
Conclusions
CCII is effective in the treatment of RA and is safe for human consumption. CCII exerts its beneficial effects by controlling inflammatory responses through inducing oral tolerance in RA patients.
Trials Registration
Clinical trial registration number: ChiCTR-TRC-00000093.