China Rheumatoid Arthritis Registry of Patients With Chinese Medicine (CERTAIN)

A multi-center registration study of clinical characteristics of rheumatoid arthritis (RA) patients with Chinese medicine.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Chinese medicine

• Study Type: Observational
• Enrollment (Anticipated): 12000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Quan Jiang, M.D; Phone Number: 86-10-88001222; Email: jiang.quan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the criteria will be enrolled from multi-centers in China.

Description

Inclusion Criteria:

• Fulfilled the rheumatoid arthritis classification criteria of 2010 American College of Rheumatology (ACR)/the European League Against Rheumatism (EULAR) .
• Aged 18 years and older.
• Be willing to accept CM therapies defined as Chinese herbal medicine, Chinese patent medicine, external treatment, acupuncture and moxibustion, etc

Exclusion Criteria:

• Refuse informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese medicine group	Other: Chinese medicine; There are no restrictions on TCM therapy, including Chinese herbal medicine, Chinese patent medicine, external treatment, acupuncture and moxibustion, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Month 12	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in [milligrams/liter] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in DAS28(CRP) at Month 12	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC-Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in [milligrams/liter] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline and month 12
Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With erythrocyte sedimentation rate (DAS28{ESR}) Remission (DAS28 <2.6) at Month 12	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 ESR utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (ESR) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.7*ln(ESR). Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and ESR= erythrocyte sedimentation rate (in millimeter/hour] mm/hr). . High score (worse outcome) and low scores (better outcome).	Month 12
Change From Baseline in DAS28(ESR) at Month 12	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 ESR utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (ESR) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.7*ln(ESR). Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and ESR= erythrocyte sedimentation rate (in millimeter/hour] mm/hr).. High score (worse outcome) and low scores (better outcome).Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline and month 12
Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points	DAS28(CRP) remission is defined as a DAS28 score of <2.6 points. The DAS index combines information relating to the number of swollen and tender joints. The DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).	through study completion, once every three months
Percentage of Participants Who Achieved DAS28(ESR) Remission (DAS28 <2.6) at All Time Points	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 ESR utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (ESR) = Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and ESR= erythrocyte sedimentation rate (in millimeter/hour] mm/hr). . High score (worse outcome) and low scores (better outcome).	through study completion, once every three months
Title:Change From Baseline in DAS28(CRP) at All Assessment Time Points	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline.	through study completion, once every three months
Title:Change From Baseline in DAS28(ESR) at All Assessment Time Points	DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 ESR utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (ESR) = Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and ESR= erythrocyte sedimentation rate (in millimeter/hour] mm/hr). . High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline.	through study completion, once every three months
Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points	DAS28(CRP) scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as follows: Current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2=good response), (>0.6 to <=1.2 = moderate response) and (<=0.6 =no response). Current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2 =moderate response), (>0.6 to <=1.2 = moderate response) and (<=0.6 =no response). Current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2=moderate response), (>0.6 to <=1.2 = no response) and (<=0.6 =no response). If the post-Baseline DAS28(CRP) score was missing, then the corresponding EULAR category was set to missing.	through study completion, once every three months
Title:Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission at All Assessment Time Points	CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Remission was achieved for a non-missing CDAI value <=2.8.	through study completion, once every three months
Title:Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at All Assessment Time Points	SDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician and acute phase reactants. The SDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal-phalangeal I-V, proximal interphalangeal I-V and knees. It is calculated using the following formula: SDAI = TJC28 + SJC28 + GH + GP + CRP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment, GP= physician assessment of disease activity using a 10 centimetre [cm] visual analogue scale [VAS] with 0 = best, 10 = worst), and CRP= C reactive Protein (in mg/L). It ranges between 0.1 and 86. High score indicates worse outcome, low score indicates better outcome. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	through study completion, once every three months
Change From Baseline in Chinese Patient-reported Activity Index with Rheumatoid Arthritis (CPRI-RA) at All Assessment Time Points	CPRI-RA is the first rheumatoid arthritis Patient Reported Outcome(Pro) scale in China that has achieved expert consensus.The scale contains 11 items, including joint pain (item 1), swelling (item 2), morning stiffness (item 3), local skin temperature (item 4), upper limb activity function (item 5), lower limb activity function (item 6), fatigue (item 7), muscle soreness (item 8), appetite (Item 9) Irritability or anxiety (item 10) and difficulty in daily life (item 11). Each item is scored 0, 1, 2 and 3 respectively according to the four grades from none to there and from light to heavy, and then the total score is calculated according to the weight.Total score calculation formula = 1.43×(item 1) + 0.93×(item 2) + 0.40×(item 3)+1. 09×(item 4)+ 0.11×(item 5) + 0.18×(item 6) + 0.24×(item 7) + 0. 04×(item 8)+ 1.17 × (Item 9)+ 0. 19 ×(item 10) + 0. 02 ×(item 11). Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	through study completion, once every three months
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at All Assessment Time Points	HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas;dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each functional area contains at least two questions. For each question, there is a four level response set that is scored from 0 (without any difficulty) to 3 (unable to do). If aids or devices or physical assistance are used for a specific functional area and the maximum response of this functional area is 0 or 1 the according value is increased to a score of 2. HAQ-DI is only calculated if there are at least 6 functional area scores available. The average of these non-missing functional area scores defines the continuous HAQ-DI score ranging from 0 to 3. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	through study completion, once every three months
Participants' sharp score or modified total Sharp score(mTSS) score of wrist bone destruction at All Assessment Time Points	Sharp evaluation is mainly a method to evaluate the bone destruction of wrist in patients with rheumatoid arthritis. The 27 parts of the hand and wrist were used as scoring points, and the scores were added from the two aspects of erosion score and narrowing degree of joint cavity: 0 for no bone erosion, 5 for extensive bone erosion and loss, and 2-4 between the two; 0 points for no stenosis, 1 point for local stenosis, 2 points for diffuse stenosis with an area of 50%, 3 points for diffuse stenosis with an area of > 50%, and 4 points for ankylosis.On this basis, van der heiide revised the mTSS to reduce the 27 scoring sites of the hand and wrist to 17 erosion evaluation sites and 18 joint cavity narrowing evaluation sites.	through study completion, once every three months
Number of Participants With Hematologic System Events at All Assessment Time Points	The participants were tested with leucocyte count,platelet count,hemoglobin content and d-dimer test for regular metabolic function evaluation.The number of participants experiencing metabolic abnormal events have been reported.	through study completion, once every three months
Number of Participants With Metabolic Abnormal Events at All Assessment Time Points	The participants were tested with blood lipid [total cholesterol(TC), triglyceride(TG), low density lipoprotein cholesterol(LDL-C)], blood glucose (Glu), liver and kidney function [aspartate aminotransferase(AST), alanine aminotransferase(ALT), gama-glutamyltransferase(GGT), Urea(Ur), Crea(Cr)] for regular metabolic function evaluation .The number of participants experiencing metabolic abnormal events have been reported.	through study completion, once every three months
Number of Participants With Cardiac Events	Electrocardiograph(ECG) and ultrasonic cardiogram were used to evaluate cardiac function.Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants experiencing Cardiac events have been reported.	Up to 24 months
Number of Participants With Pulmonary Events	Pulmonary assessments were performed to determine the number of participants with pulmonary events including persistent cough, persistent dyspnea, and persistent Diffusing capacity of the lung for carbon monoxide (DLCO). Persistent is defined as any event with duration >=15 days. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants experiencing pulmonary events have been reported.	Up to 24 months

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• Gong X, Liu WX, Li D, Peng QW, Xia CM, Chang T, Guan JZ, Song MG, Zhang FY, Tang XP, Liu Y, Liu J, Peng JY, He DY, Huang QC, Gao ML, Yu JP, Liu W, Zhang JY, Zhu YL, Hou XJ, Wang HD, Fang YF, Wang Y, Su Y, Tian XP, Su X, Meng QL, Wen SY, Wang B, Li ZG, Liu J, Jiang H, Hu Y, Li HL, Wei SF, Zhu WH, Lyu AP, Zhang C, Jiang Q; CERTAIN Group. China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN): Rationale, design, and baseline characteristics of the first 11,764 enrollees. Phytomedicine. 2022 Sep;104:154236. doi: 10.1016/j.phymed.2022.154236. Epub 2022 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 1, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 12, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Guang'anmen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No