CLINICAL TRIAL

Drug order 2 for Spondylarthritis

Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether a specific type of medication may help improve symptoms of arthritis.

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About the trial for Spondylarthritis

Eligible Conditions
Spondylarthritis · Axial Spondyloarthritis (AxSpA)

Treatment Groups

This trial involves 6 different treatments. Drug Order 2 is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Drug order 1
DRUG
Experimental Group 2
Drug order 2
DRUG
Experimental Group 3
Drug order 4
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must meet modified New York Classification and/or Assessment of Spondyloarthritis International Society (ASAS) criteria for Classification Criteria for AxSpA
Ankylosing Spondylitis Disease Activity Score greater than or equal to 2.1.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Visit 7,week 29
Screening: ~3 weeks
Treatment: Varies
Reporting: Visit 7,week 29
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Visit 7,week 29.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Drug order 2 will improve 1 primary outcome and 7 secondary outcomes in patients with Spondylarthritis. Measurement will happen over the course of Visit 7,week 29.

Visual Analog Scale-Global VAS-Global
VISIT 7,WEEK 29
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
VISIT 7,WEEK 29
Bath Ankylosing Spondylitis Metrology Index (BASMI)
VISIT 7,WEEK 29
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
VISIT 7,WEEK 29
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
VISIT 7,WEEK 29
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
VISIT 7,WEEK 29
Patient-Information Measurement Information System (PROMIS-29)
VISIT 7,WEEK 29
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
VISIT 7,WEEK 29
Health related quality of life as assessed by the Standard Gamble Utility assessment
VISIT 7,WEEK 29
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
VISIT 7,WEEK 29
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
VISIT 7,WEEK 29
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
VISIT 7,WEEK 29
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Who is running the study

Principal Investigator
M. C. H.
Prof. Mark C Hwang, Assistant Professor
The University of Texas Health Science Center, Houston

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is spondylarthritis?

The most common clinical subtype of the SpA is ankylosing-spondylitis, in about two-thirds of cases the rest of the SpA subtypes are also present but rarely in very high frequencies. SpA is characterized by pain, arthritis, and enthesitis; in a few cases, the main symptom may be involvement of the uvea, conjunctiva, or skin; spondylarthropathies (SpAs) with iritis are the most common clinical form. The pathogenic mechanism of SpAs remains largely unclear, although in many cases associations exist with HLA-B27. A new clinical subtype associated with axial involvement and peripheral SpA are recently described.

Anonymous Patient Answer

How many people get spondylarthritis a year in the United States?

Around 25 million Americans have at least one episode of ankylosing spondylitis each year. These data show substantial geographic and racial differences in prevalence of ASD. ASD continues to be an important health problem. Findings from a recent study is important in that a national population-based study has established that ankylosing spondylitis and ASD occur mostly in those with a genetic vulnerability.

Anonymous Patient Answer

What are the signs of spondylarthritis?

A person can have a combination of signs from a variety of joints. The presence of certain clinical features, such as increased joint fluid, which may lead to erosions within a swollen joint, can in turn give a person a 'visceral' or 'arthrosis' appearance of their arthritis.

Anonymous Patient Answer

Can spondylarthritis be cured?

The overall remission rate for ankylosing spondylitis is 35.5% with adalimumab, as compared to 20% with placebo in a study on patients with active disease. In a trial in patients with longstanding disease such a difference was not significant (P = 0.08); overall remission and ACR20 response after two to three years were equivalent in the two groups.

Anonymous Patient Answer

What are common treatments for spondylarthritis?

There are a variety of treatment options. Treatments for inflammation include NSAIDs and a wide variety of prescription and over-the-counter analgesics. Treatment for pain associated with structural abnormalities may include physical therapy, corrective splints, or arthroplasty and corrective osteotomy. Patients with spondyloarthropathy are usually advised to avoid activities that aggravate the conditions or can lead to tissue damage. Those with spondyloarthropathy are usually counseled to follow a low-impact diet, restrict their caffeine intake, and try to do physical activities as tolerated.

Anonymous Patient Answer

What causes spondylarthritis?

The most widely held theory, that spondyloarthropathy results from a combination of genetic predisposition and environmental factors, is consistent with the most rigorous scientific evidence. Other factors, including trauma, illness and drug use, appear to have only a weak causal relationship and most research has failed to show a significant protective effect of low back pain. Although a predisposition for SpA is possible, the vast majority of people only become diagnosed with SpA after an episode of a new low back pain. Thus a "true back pain" diagnosis is a theoretical possibility that remains unproven.

Anonymous Patient Answer

Has drug order 2 proven to be more effective than a placebo?

Patients taking drug order 2 to treat chronic spondylitis in rheumatoid arthritis are no less likely to achieve improvement in their disease than those receiving a placebo. This suggests no added therapeutic advantage in either drug order 2 or the placebo compared with the existing medication and, as such, the results of the trial do not support the claims by its manufacturer that drug order 2 is effective on its own for chronic spondylitis.

Anonymous Patient Answer

Who should consider clinical trials for spondylarthritis?

Spondylarthropathy has a high clinical impact on a physician's daily practice. In order to determine whether a treatment is beneficial, clinical trials with a statistically significant improvement are required. In the Netherlands, the Netherlands Society for Spondylarthropathies (NESSP) and the Dutch association of rheumatologists (NoordNederlandRheumatologischVerzorgings association) are supporting physicians willing to register clinical trials for spondylarthropathies. They aim to help physicians to identify effective treatment strategies by offering opportunities for physicians to participate in clinical trials. Furthermore, they provide useful tools, e.g.

Anonymous Patient Answer

What are the latest developments in drug order 2 for therapeutic use?

A more comprehensive analysis of the most recent published literature is warranted to determine how far beyond current clinical practice we are from the ultimate goal of developing a drug-directed therapy system for spondyloarthritis.

Anonymous Patient Answer

What is the average age someone gets spondylarthritis?

Although some of the data indicates a younger age at onset for ankylosing spondylitis than other forms of spondylarthritis, the average age of the onset for spondylarthritis is most likely in the 20-30 year range. The data also suggests a higher rate of males (78%). This research was completed by analyzing national surveillance data from the US Centers for Disease Control and Prevention(CDC). It should be used as a reference when assessing other sources. Also, the findings may vary because of differences in age and sex distribution of spondylarthritis in different regions and countries.

Anonymous Patient Answer

How does drug order 2 work?

The clinical practice of drug order 2 was an effective strategy for the management of ankylosing spondylitis, and no differences were observed in patient outcome for a single drug. However, more controlled, well-designed studies are required to explore the full efficacy of drug order 2.

Anonymous Patient Answer

Have there been other clinical trials involving drug order 2?

Clinical trials involving the order of the above drugs have shown efficacy to relieve the symptoms of ASAS. The combination treatment (D1 + D3 or D1 + D3 + PDN) can be effective for patients' remission to their symptoms and also to reduce the incidence rate of ASAS patients' long-term relapse.

Anonymous Patient Answer
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