Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

NCT04170504 | Completed Phase 2

• 1 other identifier: 2018YFC1705203
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blinded, placebo-controlled trial with two parallel arms. The aim of the study is to evaluate whether Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than Qing Re Huo Xue placebo combined with MTX for patients with active rheumatoid arthritis (RA).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Qing Re Huo Xue; Methotrexate; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS

  Bone marrow edema score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 75; higher scores mean a worse outcome.

  week 0, week 24

Secondary Outcomes (7)

• Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS

  week 0, week 24

• The proportion of participants with no progression in bone marrow edema and bone erosion

  week 24

• The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)

  week 4, week 12, week 24

• Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate

  week 0, week 4, week 12, week 24

• Change in Clinical Disease Activity Index (CDAI)

  week0, week4, week 12, week 24

Study Arms (2)

Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)

EXPERIMENTAL

QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks

Drug: Qing Re Huo Xue (QRHX) granule; Drug: Methotrexate

Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)

PLACEBO COMPARATOR

QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks

Drug: Methotrexate; Drug: Qing Re Huo Xue (QRHX) granule placebo

Interventions

Qing Re Huo Xue (QRHX) granule DRUG

Qing Re Huo Xue (QRHX) granule 10g bid for 24 weeks

Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)

Methotrexate DRUG

Oral methotrexate 10 mg per week for 24 weeks.

Also known as: XINYI Pharm

Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX); Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)

Qing Re Huo Xue (QRHX) granule placebo DRUG

Qing Re Huo Xue (QRHX) granule placebo 10g bid for 24 weeks

Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
• Subject has a DAS28 CRP disease activity score of \>3.2 at screening.
• Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.
• Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
• Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.

You may not qualify if:

• History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
• Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.
• Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.
• Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Quan Jiang, M.D

  Guang' anmen hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 20, 2019
• Study Start: November 14, 2019
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)