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Rheumatoid ArthritisPhase 2/3NCT04170504

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

A Phase 2/3 study testing Qing Re Huo Xue (QRHX) granule and Methotrexate in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Qing Re Huo Xue (QRHX) granule and Methotrexate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
1 siteChina
Study dates
14 Nov 2019to 28 Jun 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing, 100053

Other trials in China

About this study

Official title: Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial

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).

Read the detailed description

To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10g bid and MTX 10mg once a week for 24 weeks, or MTX plus QRHX placebo. The primary outcome is the bone marrow edema score in Outcome Measures in Rheumatology Clinical Trials RA MRI Scoring (OMERACT-RAMRIS) at week 24.

Being tested
Qing Re Huo Xue (QRHX) granule, Methotrexate, Qing Re Huo Xue (QRHX) granule placebo
Keywords
Rheumatoid Arthritis, Qing Re Huo Xue, Methotrexate, Randomized controlled trial
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qing Re Huo Xue (QRHX) granuleDrug

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

  • MethotrexateDrug

    Also called XINYI Pharm

    Oral methotrexate 10 mg per week for 24 weeks.

  • Qing Re Huo Xue (QRHX) granule placeboDrug

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

Study groups in NCT04170504
Study groupRoleWhat they receive
Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)ExperimentalQRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks
Receives: Drug: Qing Re Huo Xue (QRHX) granule; Drug: Methotrexate
Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)Placebo comparatorQRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks
Receives: Drug: Methotrexate; Drug: Qing Re Huo Xue (QRHX) granule placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 0, week 24

Secondary outcomes (7)

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

    Bone erosion score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 250; higher scores mean a worse outcome.

    Measured: week 0, week 24

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

    No progression in bone marrow edema and bone erosion at week 24 is defined as change in RAMRIS osteitis/erosion score ≤0.

    Measured: week 24

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

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

    Measured: week 4, week 12, week 24

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

    The improvement of DAS28-ESR and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as DAS28-ESR \<2.6.

    Measured: week 0, week 4, week 12, week 24

  5. Change in Clinical Disease Activity Index (CDAI)

    The improvement of CDAI and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as CDAI \<2.8.

    Measured: week0, week4, week 12, week 24

  6. Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA)

    CPRI-RA,The self-rating scale consists of 11 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.

    Measured: week0, week 4, week 12, week 24

  7. Change in Health Assessment Questionnaire Disability Index (HAQ-DI)

    The self-rating scale consists of 20 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively. (range: 0 [best] to 3 [worst])

    Measured: week0, week4, week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start14 Nov 2019
  3. Primary completion28 Jun 2022
  4. Study completion28 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04170504
Sponsor's protocol ID
2018YFC1705203
Status last verified
Sep 2024
First submitted
14 Nov 2019
Last updated
23 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Qing Re Huo Xue (QRHX) granule and Methotrexate in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS (time frame: week 0, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04170504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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