Rheumatoid ArthritisPhase 1NCT01123655

Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients

A Phase 1 study testing APLA12 in people with Rheumatoid Arthritis, run by VA Office of Research and Development at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: APLA12
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Sep 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must meet the following criteria for participation in the study.
Male or female; age > 18 years.
American College of Rheumatology (ACR) 1988 revised criteria for rheumatoid arthritis.
Onset of disease age 16 or older.
Onset of disease at least 3 months prior to enrollment.
RA patients ages 18-85 with RA of 3 month duration which in the opinion of the examining rheumatologist is "clinically stable" and will likely not require adjustment of doses of Disease-modifying antirheumatic drugs (DMARDS), NSAIDS, prednisone, anti-tumor necrosis factor (anti-TNF) alpha therapies for the 16 weeks of the treatment phase of the study.

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Patients must agree to discontinue all "herbal remedies" as described in this protocol.
Women of childbearing age will be advised to use effective means of contraception for the treatment phase of the trial and for 90 days thereafter. They must have a negative urine pregnancy test at the randomization visit. (Required by the FDA.)
Men will be advised to use effective means of contraception for the treatment phase of the trial and for 90 days thereafter. (Required by the FDA.)
Crohn's Disease Activity Index (CDAI) less than or equal to 30 at the baseline visit.
Patients with a past history of malignant neoplasm will be eligible if they are 1 or greater years with no recurrence of malignant neoplasm.

Who cannot join

Inability to render an informed consent in accordance with institutional guidelines.
Participation in another clinical research study involving the evaluation of another investigational drug within 90 days of entry into this study.
RA patients on >7.5 mg prednisone a day.
RA patients with intra-articular corticosteroid injections during the previous 30 days.
Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for the study. Hepatitis B abd/or C patients with inactive disease (as determined by PI) will be enrolled.
Positive urine pregnancy test

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Age 85 years or greater.
Use of "fish oil" within the previous 4 weeks of the baseline visit.
Therapy consisting of auranofin or cyclophosphamide (all other DMARDs are allowed).
Previous autologous or heterologous stem cell transplantation.
Active malignant neoplasm or past treatment for malignant neoplasm 1 year from screening visit.
Use of oral CII within the past 1 year. (Since oral tolerance is short-lived, we will permit patients in the study who have been off oral CII for > 1 year)
Diabetes requiring insulin or on oral medications must be well managed at baseline. Adjustment of insulin or on oral medications will be allowed during the study.
Serum creatinine 2.0 mcg/dL.
An 1(II) IFN value <100% of the PBS IFN value within 1 month or less prior to the baseline and less than 25% reduction in APL A12 + 1(II) IFN from 1(II) IFN concentration.
CDAI > 30 at the baseline visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104

Other trials in United States

About this study

Official title: Phase 1 Trial of CII APL A12 in Rheumatoid Arthritis Patients

This is a Phase I clinical trial to determine whether orally administered APL A12 at one or more doses is superior to placebo in effecting a 25% reduction in interferon (IFN) stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In an effort to learn more about the mechanism of action of APL A12, the investigators will assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+ CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry combined with intracellular cytokine staining will be used in an effort to determine which T cell subset(s) is/are experiencing shifts in cytokine expression.

Read the detailed description

The study will have 3 treatment arms each with 10 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 3 treatment arms. Each of the 3 treatments will be given for 16 weeks.

In keeping with a sequential dose escalation strategy, the originally proposed randomization scheme will be modified so that subjects will be randomized to receive either the lowest dose (30 mg) or placebo (Block 1), followed by the next dose (50 mg) or placebo (Block 2). We will begin with the lowest dose (30 g/day) and enroll 6 to receive 30 g/day APL A12 and 2 to receive placebo for 16 weeks. Results will be reported to the Data Monitoring Committee (DMC) for a decision to proceed to the next block based on indications of safety. If this dose does not cause adverse events or toxicity or worsens RA, we will proceed to enroll patients to receive 30 ug, or 50 g/day APL A12 or placebo for 16 weeks. A total of 32 subjects will be randomized to obtain 24 subjects who complete the study. Recruitment was difficult. Only 22 patients were randomized. There were not enough 50mcg patients enrolled so 2 treatment groups was analyzed. Arm 1 included 30 and 50 mcg and Arm 2 represents the patients that received placebo.

Conditions: Rheumatoid Arthritis
Being tested: APLA12, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

APLA12Drug
Intervention: Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.
PlaceboDrug
Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.

Study groups in NCT01123655
Study group	Role	What they receive
Arm 1	Experimental	The study will have 3 treatment arms each with 10-12 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 2 treatment arms (30 micrograms APL A12 or placebo). Each of the 2 treatments will be given for 16 weeks. Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. Receives: Drug: APLA12; Drug: Placebo
Arm 2	Experimental	The next group will receive a higher dose (50 micrograms) and/or placebo (Block 2). Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. Receives: Drug: APLA12; Drug: Placebo
Arm 3	Experimental	Block 3 (Arm 3) will include placebo and both doses of APL/A12 to ensure 10-12 patients are enrolled in each arm ( total of approximately 32 subjects) so we will have 24 subjects who complete the 16 weeks of study treatment. Arms 2 and 3 will run simultaneously. Intervention: Drug treatment will be stopped or interrupted if indicated. Receives: Drug: APLA12; Drug: Placebo

What is being measured

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

Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment.
The primary outcome variable is the presence of a > 25% reduction in net IFN concentration in supernatants of 1(II)-stimulated PBMC cultures from baseline after 16 weeks of treatment.
Measured: 16 weeks

Secondary outcomes (33)

Flow Cytometry
Change in Percentage of CD4+CD25+FoxP3 T regulatory cells, CD4+IL-10+ cells, CD4+ IL-4+ cells, CD4+IL17+ cells. Some patients had only had enough blood collected at 8 weeks or 16 weeks or dropped out after 8 weeks, and we used/combined what was available.
Measured: baseline and 8 or 16 weeks
Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up
Interpretation of Clinical Disease Activity Index (CDAI) scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity.
Measured: 0 and16 weeks
Change in Cytokine Profile From Baseline and 16 Weeks
Cytokines assessed are IL-10, IL-13, IL-5, IL-1B, IL-9, IL-17A, IL-6, IL-21, TGF-B, TNFa,and MIP3A.
Measured: 0 and 16 weeks
Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks
The change was computed between baseline and 8 or 16 weeks, whichever was available.
Measured: baseline and 8 or 16 wks
Neutrophils Counts at 0 and 16 Weeks
Laboratory Results of A12 vs Placebo:Complete blood count Neutrophil count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: Baseline and 16 weeks
A12 Treated vs Placebo of Monocytes.
Laboratory Results of A12 treated vs Placebo of Monocytes to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: Baseline and 16 wks
Eosinophils
Laboratory Results of A12 treated vs Placebo of Eosinophils to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: Baseline and 16 weeks
Laboratory Results of A12 vs Placebo: Lymphocytes
Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Laboratory Results of A12 vs Placebo: Basophils
Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: Baseline and 16 weeks
Hematocrit
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes)
Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: Baseline and 16 weeks
Red Blood Cell Distribution Width (RDW)
Laboratory Results of A12 vs Placebo RDW is a measure of the range of variation of red blood cell volume reported as part of a standard blood count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0 and 16 weeks
Hemaglobin
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: Baseline and 16 weeks
Red Blood Cells
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
White Blood Count
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Platelets
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
AST, ALT and Alkaline Phosphatase
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Ca, BUN, Glucose,Creatinine, Total Bilirubin
Laboratory Results of A12 vs Placebo-CMP to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Sodium, Potassium and Chloride
Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Total Protein, Albumin
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
C-reactive Protein
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Rheumatoid Factor
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Sedimentation Rate
Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Measured: 0-16 weeks
Laboratory Results of A12 vs Placebo Anti-CCP Antibody
Measured: 0-16 weeks
Patient Global Assessment (PGA) and Physician Global Assessment
Patient and Physician (PI) Assessments both range from 0-10 with 10 being the most disease activity
Measured: 0-16 weeks
Modified Health Assessment Questionnaire (MHAQ)
Modified Health Assessment Questionnaire (MHAQ) 0-8 with 8 being the most activity
Measured: 0-16 weeks
Duration of Morning Stiffness in Joints
Duration of morning stiffness in the joints, in minutes.
Measured: 0-16 weeks
CDAI
Clinical Disease Activity Index (CDAI) 0-76 mm. Interpretation of CDAI scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity.
Measured: 0-16 weeks
Vital Signs-Temperature
Measured: 0-16 weeks
Vital Sign - Pulse
heartbeats per minute
Measured: 0-16 weeks
Weight
Weight in kg
Measured: 0-16 weeks
Vitals - Blood Pressure
measurement of blood pressure (mmHg)
Measured: 0 weeks and 16 weeks
Vitals - Respirations
Respirations represents breaths per minute
Measured: 0 weeks and 16 weeks

Timeline

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

Oct 2009Sep 2015

First posted14 May 2010 (estimated)
Study startOct 2009
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01123655
Sponsor's protocol ID: IMMA-007-08S
Status last verified: Dec 2018
First submitted: 12 May 2010
Last updated: 19 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Trial of CII APL A12 in Rheumatoid Arthritis Patients
ClinicalTrials.gov ID: NCT01123655
Acronym / sponsor ID: IMMA-007-08S
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Oct 2009
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 14 May 2010 (estimated)
Results: Posted 19 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm 1	Experimental	Drug: APLA12, Drug: PlaceboThe study will have 3 treatment arms each with 10-12 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 2 treatment arms (30 micrograms APL A12 or placebo). Each of the 2 treatments will be given for 16 weeks. Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate.
Arm 2	Experimental	Drug: APLA12, Drug: PlaceboThe next group will receive a higher dose (50 micrograms) and/or placebo (Block 2). Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate.
Arm 3	Experimental	Drug: APLA12, Drug: PlaceboBlock 3 (Arm 3) will include placebo and both doses of APL/A12 to ensure 10-12 patients are enrolled in each arm ( total of approximately 32 subjects) so we will have 24 subjects who complete the 16 weeks of study treatment. Arms 2 and 3 will run simultaneously. Intervention: Drug treatment will be stopped or interrupted if indicated.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients must meet the following criteria for participation in the study.
Male or female; age > 18 years.
American College of Rheumatology (ACR) 1988 revised criteria for rheumatoid arthritis.
Onset of disease age 16 or older.
Onset of disease at least 3 months prior to enrollment.

Key exclusion criteria (16 listed)

Inability to render an informed consent in accordance with institutional guidelines.
Participation in another clinical research study involving the evaluation of another investigational drug within 90 days of entry into this study.
RA patients on >7.5 mg prednisone a day.
RA patients with intra-articular corticosteroid injections during the previous 30 days.
Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for the study. Hepatitis B abd/or C patients with inactive disease (as determined by PI) will be enrolled.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
APLA12Intervention: Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.	Drug	Arm 1, Arm 2, Arm 3
PlaceboDrug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.	Drug	Arm 1, Arm 2, Arm 3

Primary outcome

Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment.
Time frame: 16 weeks
The primary outcome variable is the presence of a > 25% reduction in net IFN concentration in supernatants of 1(II)-stimulated PBMC cultures from baseline after 16 weeks of treatment.

33 secondary outcomes

Flow Cytometry
Time frame: baseline and 8 or 16 weeks
Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up
Time frame: 0 and16 weeks
Change in Cytokine Profile From Baseline and 16 Weeks
Time frame: 0 and 16 weeks
Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks
Time frame: baseline and 8 or 16 wks
Neutrophils Counts at 0 and 16 Weeks
Time frame: Baseline and 16 weeks
A12 Treated vs Placebo of Monocytes.
Time frame: Baseline and 16 wks
Eosinophils
Time frame: Baseline and 16 weeks
Laboratory Results of A12 vs Placebo: Lymphocytes
Time frame: 0-16 weeks
Laboratory Results of A12 vs Placebo: Basophils
Time frame: Baseline and 16 weeks
Hematocrit
Time frame: 0-16 weeks
Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes)
Time frame: Baseline and 16 weeks
Red Blood Cell Distribution Width (RDW)
Time frame: 0 and 16 weeks
Hemaglobin
Time frame: Baseline and 16 weeks
Red Blood Cells
Time frame: 0-16 weeks
White Blood Count
Time frame: 0-16 weeks
Platelets
Time frame: 0-16 weeks
AST, ALT and Alkaline Phosphatase
Time frame: 0-16 weeks
Ca, BUN, Glucose,Creatinine, Total Bilirubin
Time frame: 0-16 weeks
Sodium, Potassium and Chloride
Time frame: 0-16 weeks
Total Protein, Albumin
Time frame: 0-16 weeks
C-reactive Protein
Time frame: 0-16 weeks
Rheumatoid Factor
Time frame: 0-16 weeks
Sedimentation Rate
Time frame: 0-16 weeks
Laboratory Results of A12 vs Placebo Anti-CCP Antibody
Time frame: 0-16 weeks
Patient Global Assessment (PGA) and Physician Global Assessment
Time frame: 0-16 weeks
Modified Health Assessment Questionnaire (MHAQ)
Time frame: 0-16 weeks
Duration of Morning Stiffness in Joints
Time frame: 0-16 weeks
CDAI
Time frame: 0-16 weeks
Vital Signs-Temperature
Time frame: 0-16 weeks
Vital Sign - Pulse
Time frame: 0-16 weeks
Weight
Time frame: 0-16 weeks
Vitals - Blood Pressure
Time frame: 0 weeks and 16 weeks
Vitals - Respirations
Time frame: 0 weeks and 16 weeks

Results and safety

Results posted to the registry on 19 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
30 mcg of APL/Day	10	9
50 ug APL/Day	4	3
Placebo	8	7

Primary outcome: Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment.

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	APL 30 and 50ug/Day n = 10	Placebo n = 6
Value	9	4

APL 30 and 50ug/Day vs Placebo: p = 0.5179, Fisher Exact
APL 30 and 50ug/Day: p = 0.0114, Exact Test
Placebo: p = 0.4142, Exact Test

Population analysed: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements

33 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
30 ug and 50 ug APL/Day	2 of 14 (14.3%)	8 of 14 (57.1%)	1 of 14
Placebo	0 of 8 (0%)	6 of 8 (75%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arnold E Postlethwaite, MD principal investigator

Memphis VA Medical Center, Memphis, TN

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing APLA12 in people with Rheumatoid Arthritis, run by VA Office of Research and Development at 1 site in United States.

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 11 inclusion and 16 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 19 Mar 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment. (time frame: 16 weeks). 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 NCT01123655.

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 19 Mar 2019.