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Abatacept for Common Variable Immunodeficiency

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, San Francisco, CACommon Variable Immunodeficiency+1 MoreAbatacept - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at whether abatacept is effective for treating granulomatous-lymphocytic interstitial lung disease in people with common variable immunodeficiency.

Eligible Conditions
  • Common Variable Immunodeficiency
  • Interstitial Lung Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Romiplostim
1
Inebilizumab
1
Abatacept

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: 6months, 12 months

6 months
High Resolution CT Scan of the chest (HRCT)
6 months, 12 months
Additional Immune Agents
Adverse Events/Serious Adverse Events
Change in King's Interstitial Lung Disease scores
Change in PedsQL (Pediatric Quality of Life) Generic Core scores
Change in Short Form-36 scores
Complications of concurrent infections
Diffusion capacity of carbon monoxide (DLCo)
Dropout rate
Forced expiratory volume (FEV)
Forced vital capacity (FVC)
Incidence
Incidence of concurrent infections
Pediatric growth - change in height
Pediatric growth - change in weight
Resolution
Survival
Treatment of concurrent infections
6months, 12 months
Steroid usage

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Romiplostim
2
Inebilizumab
1
Abatacept

Side Effects for

IV ABATACEPT
85%NASOPHARYNGITIS
60%PHARYNGITIS
50%INFLUENZA
35%STOMATITIS
35%LIGAMENT SPRAIN
35%HEADACHE
30%CONTUSION
30%UPPER RESPIRATORY TRACT INFLAMMATION
25%ACNE
25%DIARRHOEA
25%ARTHRALGIA
25%SEASONAL ALLERGY
25%BRONCHITIS
20%UPPER RESPIRATORY TRACT INFECTION
20%PYREXIA
20%NAUSEA
20%GASTROENTERITIS
15%VOMITING
15%EPISTAXIS
15%RHINITIS ALLERGIC
15%COUGH
15%VIRAL PHARYNGITIS
15%RHINITIS
15%SKIN PAPILLOMA
15%CONJUNCTIVITIS
15%RASH
10%MYALGIA
10%ALOPECIA
10%DRY EYE
10%CONSTIPATION
10%ARTHROPOD BITE
10%DRY SKIN
10%TOOTHACHE
10%SKIN ABRASION
10%DERMATITIS
10%JUVENILE IDIOPATHIC ARTHRITIS
10%PAIN IN EXTREMITY
10%APHTHOUS ULCER
10%ANGULAR CHEILITIS
10%INFLUENZA B VIRUS TEST POSITIVE
10%PURPURA
10%TENDONITIS
10%ABDOMINAL PAIN
10%ABDOMINAL PAIN UPPER
10%BACK PAIN
10%ENTEROCOLITIS VIRAL
10%RHINORRHOEA
10%ECZEMA
5%VIRAL TONSILLITIS
5%VARICELLA
5%LOWER LIMB FRACTURE
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT01835470) in the IV ABATACEPT ARM group. Side effects include: NASOPHARYNGITIS with 85%, PHARYNGITIS with 60%, INFLUENZA with 50%, STOMATITIS with 35%, LIGAMENT SPRAIN with 35%.

Trial Design

2 Treatment Groups

Abatacept
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Abatacept · Has Placebo Group · Phase 2

Abatacept
Drug
Experimental Group · 1 Intervention: Abatacept · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6months, 12 months

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
763 Previous Clinical Trials
5,421,779 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,510 Previous Clinical Trials
3,944,283 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You cannot have a weakened immune system caused by another medical condition.
You are okay with your biological samples being stored for future medical research.
You have been taking immunoglobulin replacement therapy for at least 6 months and are willing to continue taking it during the study.
References

Frequently Asked Questions

Are there any dangers associated with Abatacept?

"There is some data supporting the safety of Abatacept, but none yet for efficacy. We've given it a score of 2." - Anonymous Online Contributor

Unverified Answer

What are some of the most popular reasons that doctors prescribe Abatacept?

"Abatacept is a medication prescribed to patients with [rheumatoid arthritis](https://www.withpower.com/clinical-trials/rheumatoid-arthritis). It's also used to mitigate the symptoms of psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis." - Anonymous Online Contributor

Unverified Answer

Are there still places available for people who want to participate in this research?

"Yes, as of 9/9/2022 this trial is still looking for participants. The listing was created on 7/14/2021." - Anonymous Online Contributor

Unverified Answer

Are there any other similar cases in which Abatacept has been used?

"Currently, there are 36 ongoing studies investigating abatacept. 8 of those trials have reached Phase 3 clinical testing. The majority of these investigations into abatacept's efficacy are taking place in Toronto, but there are a total of 772 research sites worldwide." - Anonymous Online Contributor

Unverified Answer

How many people are signing up to be a part of this test group?

"Yes, as specified on clinicaltrials.gov, this study is recruiting patients. The trial was posted on 7/14/2021 and updated on 9/9/2022. They are looking for 60 participants from 1 site." - Anonymous Online Contributor

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

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