CLINICAL TRIAL

Certolizumab pegol for Arthritis

Waitlist Available · 18+ · All Sexes · Albuquerque, NM

This study is evaluating whether a drug may help treat rheumatoid arthritis.

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About the trial for Arthritis

Eligible Conditions
Arthritis · Arthritis, Rheumatoid · Rheumatoid Arthritis

Treatment Groups

This trial involves 2 different treatments. Certolizumab Pegol is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Certolizumab pegol
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Certolizumab pegol
FDA approved

Side Effect Profile for Run-in Overall

Run-in Overall
Show all side effects
13%
Upper respiratory tract infection
8%
Urinary tract infection
3%
Arthralgia
3%
Rheumatoid arthritis
2%
Nasopharyngitis
1%
Pneumonia
1%
Cellulitis
0%
Pneumonia pneumococcal
0%
Painful respiration
0%
Thrombocytopenia
0%
Pelvic peritoneal adhesions
0%
Dermal cyst
0%
Kidney infection
0%
Coronary artery occlusion
0%
Oral candidiasis
0%
Ventricular tachycardia
0%
Abdominal pain
0%
Basal cell carcinoma
0%
Back pain
0%
Chest pain
0%
Pericardial effusion
0%
Drug toxicity
0%
Gastrointestinal haemorrhage
0%
Pyrexia
0%
Musculoskeletal chest pain
0%
Pancytopenia
0%
Dyspnoea
0%
Epistaxis
0%
Herpes pharyngitis
0%
Pyelonephritis
0%
Colitis
0%
Coronary artery disease
0%
Angina pectoris
0%
Osteoarthritis
0%
Depression
0%
Renal failure acute
0%
Implantable defibrillator insertion
0%
Lupus-like syndrome
0%
Bursitis
Upper respiratory tract infection
13%
Urinary tract infection
8%
Arthralgia
3%
Rheumatoid arthritis
3%
Nasopharyngitis
2%
Pneumonia
1%
Cellulitis
1%
Pneumonia pneumococcal
0%
Painful respiration
0%
Thrombocytopenia
0%
Pelvic peritoneal adhesions
0%
Dermal cyst
0%
Kidney infection
0%
Coronary artery occlusion
0%
Oral candidiasis
0%
Ventricular tachycardia
0%
Abdominal pain
0%
Basal cell carcinoma
0%
Back pain
0%
Chest pain
0%
Pericardial effusion
0%
Drug toxicity
0%
Gastrointestinal haemorrhage
0%
Pyrexia
0%
Musculoskeletal chest pain
0%
Pancytopenia
0%
Dyspnoea
0%
Epistaxis
0%
Herpes pharyngitis
0%
Pyelonephritis
0%
Colitis
0%
Coronary artery disease
0%
Angina pectoris
0%
Osteoarthritis
0%
Depression
0%
Renal failure acute
0%
Implantable defibrillator insertion
0%
Lupus-like syndrome
0%
Bursitis
0%
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT00580840) in the Run-in Overall ARM group. Side effects include: Upper respiratory tract infection with 13%, Urinary tract infection with 8%, Arthralgia with 3%, Rheumatoid arthritis with 3%, Nasopharyngitis with 2%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The participant must be between 18 and 69 years old when they sign the informed consent form. show original
Someone who has RA is diagnosed as having moderately-to-severely active RA if their RA is currently moderately-to-severely active. show original
Someone who has had an inadequate response to or intolerance to at least one disease-modifying antirheumatic drug (DMARD) is eligible for the study show original
The participant has a negative result on the interferon-gamma release assay (IGRA) at the screening test. show original
The participant has a body mass index that falls between 18.0 kg/m2 and 35.0 kg/m2. show original
A woman who is not of childbearing potential or who agrees to follow the contraceptive guidance during the Treatment Period and until the Safety Follow-up VISit. show original
Male or female
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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: Baseline and during Weeks 1, 2, 6, 10, 11, 12, 18 and 24
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline and during Weeks 1, 2, 6, 10, 11, 12, 18 and 24
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and during Weeks 1, 2, 6, 10, 11, 12, 18 and 24.
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 Certolizumab pegol will improve 2 primary outcomes and 3 secondary outcomes in patients with Arthritis. Measurement will happen over the course of From Baseline to the the Safety Follow-up Visit (up to Week 34).

Incidence of Treatment-Emergent Serious Adverse Event (SAEs)
FROM BASELINE TO THE THE SAFETY FOLLOW-UP VISIT (UP TO WEEK 34)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
FROM BASELINE TO THE THE SAFETY FOLLOW-UP VISIT (UP TO WEEK 34)
Incidence of Treatment-emergent (TEAEs) leading to withdrawal
FROM BASELINE TO THE THE SAFETY FOLLOW-UP VISIT (UP TO WEEK 34)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
FROM BASELINE TO THE THE SAFETY FOLLOW-UP VISIT (UP TO WEEK 34)
Minimum observed plasma concentration (Cmin) after 10 weeks of certolizumab pegol dosing
FROM WEEK 10 TO WEEK 12
Cmin: Minimum observed plasma concentration
FROM WEEK 10 TO WEEK 12
Area under the concentration-time curve over one dosing interval (AUCtau) of certolizumab pegol
FROM WEEK 10 TO WEEK 12
AUCtau: Area under the concentration-time curve over one dosing interval
FROM WEEK 10 TO WEEK 12
Plasma Concentration of Certolizumab Pegol (CZP) during the study
BASELINE AND DURING WEEKS 1, 2, 6, 10, 11, 12, 18 AND 24
Plasma samples will be taken at Baseline and during the study for all subjects.
BASELINE AND DURING WEEKS 1, 2, 6, 10, 11, 12, 18 AND 24

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 are the signs of arthritis?

Many patients with arthritis experience joint pain. Certain types of pain such as joint swelling, joint tenderness and iritis may be due to an underlying infection, inflammation in the joints or an underlying degenerative joint disease.

Anonymous Patient Answer

Can arthritis be cured?

Arthritis cannot be cured. There are no medications so that arthritis will not flare up again, but there are various treatments which can help alleviate symptoms and reduce joint damage. So the answer is yes, arthritis can be better controlled.

Anonymous Patient Answer

What are common treatments for arthritis?

Therapies and medications used to treat arthritis are similar to those reported for other conditions. Common medications include analgesics (painkillers), non-steroidal anti-inflammatory drugs (NSAIDS), methotrexate and hydroxychloroquine, and a combination of these. Common anti-rheumatic therapies include physiotherapy and injections of glucocorticoids, hyaluronic acid or methotrexate.

Anonymous Patient Answer

What causes arthritis?

Many different factors are involved, including genetics, environmental exposure and inflammation. However, the relationship between all of these factors in the development of arthritis is not yet fully understood.

Anonymous Patient Answer

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

Around 57 (61) million US adults are thought to have been diagnosed with arthritis in their lifetime. The proportion of women having ever been diagnosed with arthritis (61.1%) is higher than men (31.5%). The most common types of arthritis (overall) are: arthritic spondyloarthropathy, connective tissue disorders, inflammatory polyarthritis, oligoarthritis, OA, and gout. The proportion of women who have been diagnosed with arthritis is higher than men, however once a diagnosis of arthritis was made; the proportion of women were diagnosed with arthritis decreased and men with arthritis increased. This may be due to women having earlier presentation of OA for diagnosis.

Anonymous Patient Answer

What is arthritis?

Arthritis is an inflammatory disease characterized by chronic and painful inflammation, pain, tenderness, and tenderness, swelling, and stiffness in one or more joints. Most [rheumatoid arthritis](https://www.withpower.com/clinical-trials/rheumatoid-arthritis) (RA) and osteoarthritis (OA) cases usually occur in middle-aged adults, and more than 90% of persons who have arthritis have underlying rheumatoid factor antibodies. The signs and symptoms of arthritis include: pain and/or swelling in one or more joint(s), tenderness and/or aching in one or more joint(s), redness of the skin around joint(s), warmth in one or more joint(s), and/or inability to do active movements with the joint(s).

Anonymous Patient Answer

Is certolizumab pegol safe for people?

CPT is well tolerated, but rare adverse events are observed, mainly involving the skin and intestine. A single case report of a fatal complication linked to an autoimmune reaction to the drug is possible, and caution is needed when administering it in older people.

Anonymous Patient Answer

Have there been any new discoveries for treating arthritis?

Recent researches by Dr. Keck have also revealed new medications and therapies that reduce pain as well as improve the functionality of the joints. He is a leader in researching these types of treatments for arthritis. Many of them were developed at USC. I hope this information provides you with enough information to make an informed choice on whether to try these therapies or not.

Anonymous Patient Answer

What is the primary cause of arthritis?

In about 60% rheumatoid patients, at the moment when symptoms are first noticed and treated, arthritis in the affected joint(s) is the result of an underlying autoimmune process in which different kinds of immune system responses lead to joint inflammation, damage and loss of joint function. By blocking these attacks, the most common form of rheumatoid arthritis can be effectively controlled with treatment. In almost half of all patients, however, arthritis is the first symptom of an underlying systemic autoimmune disorder which causes the disease to spread throughout the body and eventually affects almost all joints. The treatment of this type of arthritis involves specific treatment for the underlying disease.

Anonymous Patient Answer

What are the latest developments in certolizumab pegol for therapeutic use?

The use of CMP for RA treatment and as a monotherapy shows comparable efficacy and acceptable safety in all evaluated trials. Moreover, the clinical benefit of CMP shows a dose-dependent efficacy in the treatment of patients with disease flares, justifying CMP continuing to be a first-line option for the induction of initial and sustained responses in RA with treatment-experienced patients with disease flares of moderate to severe disease activity. Considering these results, CMP can be considered a first-line agent in the treatment of patients with RA.

Anonymous Patient Answer

What is the average age someone gets arthritis?

About 40% of people had arthritis by 21; most were diagnosed before this. There were more women than men - about half of the cases. The prevalence was highest in the 15-19, 5-9, and 0-4 yr age groups.

Anonymous Patient Answer

How does certolizumab pegol work?

Data from a recent study suggests that certolizumab pegol has a unique profile in its ability to cause autoantibody formation and an IgM switch in PBMCs and to modulate PBMC subsets by a mechanism of IL-10 induction in vitro.

Anonymous Patient Answer
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