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Compares treatment options for Ankylosing Spondylitis
Official title A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
ClinicalTrials.gov ID: NCT06000956
What this study is testing
What is Jitongning tablets?
Jitongning tablets is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for ankylosing spondylitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are: Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- All of the following standards must be met:
- Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
- Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for...
- Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;
- CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);
You likely can't join if
- Those who meet any of the following criteria cannot be included in this experiment:
- Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;
- Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction...
- Received spinal or joint surgery treatment within 8 weeks prior to enrollment;
- Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;
- Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;
See the full eligibility criteria
- All of the following standards must be met:
- Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
- Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for determining disease activity are to meet two criteria: Bass ankylosing...
- Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;
- CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);
- Human leukocyte antigen B27 (HLA-B27) is positive;
- Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR);
- Voluntarily participate in this clinical trial and sign an informed consent form.
- Those who meet any of the following criteria cannot be included in this experiment:
- Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;
- Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction, chemical drugs (such as sulfasalazine, methotrexate, leflunomide...
- Received spinal or joint surgery treatment within 8 weeks prior to enrollment;
- Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;
- Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;
- CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;
- people diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;
- Those who have fertility requirements within six months;
- Pregnant or lactating women;
- Suspected or actual drug, substance, or alcohol abuse;
- Within 3 months prior to the trial or currently participating in clinical trials;
- Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events;
- Abnormal liver function (elevated levels of alanine or alanine aminotransferase above the upper limit of normal values); Abnormal renal function (serum creatinine levels above the upper limit of normal values);
- The researchers believe that it is not suitable to participate in this experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Lanzhou, Gansu, China
- Shijiazhuang, Hebei, China
- Luoyang, Henan, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Nanchong, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Lanzhou, Gansu, China; Shijiazhuang, Hebei, China; Luoyang, Henan, China; Wuhan, Hubei, China; Suzhou, Jiangsu, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.