Autoimmune DiseasesPhase 1NCT03656627
Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
A Phase 1 study testing Nivolumab in people with Autoimmune Diseases and Non-small Cell Lung Cancer, run by Alliance Foundation Trials, LLC. at 9 sites in United States.
Trial summary
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Non-small Cell Lung Cancer, Rheumatoid Arthritis
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Jun 2019to 18 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Metastatic, locally advanced or recurrent NSCLC, not amenable to curative therapy.
- Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy.
- Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy
- No limit on number of prior therapies
Show all 27Show fewer
- Ability to provide written, informed consent
- Patients must be on a stable regimen of treatment for their autoimmune condition without need for addition of new medications or escalating doses of preexisting medications in the previous 12 weeks prior to study entry
- In addition, patients with the following autoimmune diseases must have baseline disease activity scores as follows (please see Appendix A):
- For rheumatoid arthritis: DAS28 < 5.1
- For polymyalgia rheumatica: PMR-AS < 17
- For Sjogrens: ESSDAI < 14
- For ulcerative colitis: SSCAI < 5
- For Crohn's disease: CDAI < 450
- For systemic lupus erythroderma: SLEDAI-2K < 20
- For multiple sclerosis: EDSS < 5.5
- Adequate organ and marrow function as defined by:
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcL
- total bilirubin ≤ 2.5 × institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal, OR
- AST(SGOT)/ALT(SGPT ) ≤5 × institutional upper limit of normal if liver metastases are present
- Creatinine within normal institutional limits OR
- Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Non-pregnant and non-nursing.
- Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses > 1 year.
- Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
Who cannot join
- No chemotherapy or radiotherapy within two weeks of study entry. Prior targeted therapy is allowed as long as at least 5 half-lives have elapsed since last dose.
- All adverse events (other than alopecia) from prior therapy must be resolved to Grade 1 or less.
- Patients who are known to be HIV positive are excluded due to the known immunologic alterations associated with the disease. HIV testing is not required.
- No uncontrolled intercurrent illness such as active infection, or psychiatric illness or social situation that in the judgment of the investigator would limit compliance with study requirements
- No active interstitial lung disease (ILD) or pneumonitis, or a history of ILD or pneumonitis requiring treatment with corticosteroids
- No live vaccine within 30 days of start of study treatment
Show all 11Show fewer
- No carcinomatous meningitis or untreated CNS metastases
- No history of significant cardiac disease or presence of an abnormality in electrocardiograms that, in the investigator's opinion, is medically exclusionary or clinically meaningful
- No other active malignancy
- No known history of or positivity for active hepatitis B or C. HBV DNA and/or HCV RNA must be undetectable and HBsAg must be negative at the time of screening
- No active unstable angina and/or congestive heart failure, or myocardial infarction within 6 months prior to protocol participation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Chicago Medical Center
Chicago, Illinois, 60637
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus, Ohio, 43210
Dartmouth Hitchcock Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
About this study
Official title: Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type.
Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.
Read the detailed description
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type as outlined below. Entry into cohorts 1 and 2 will start simultaneously and enroll independently.
Cohort 1: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis Cohort 2: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment.
Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level.
Participants will be followed with telephone follow up for two years after removal from protocol therapy or until death, whichever occurs first. Phone calls will be placed every six months and survival follow up obtained. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event, in addition to the follow up for two years after removal from protocol therapy or until death, whichever occurs first.
- Conditions
- Autoimmune Diseases, Non-small Cell Lung Cancer, Rheumatoid Arthritis, Psoriasis, Giant Cell Arteritis, Polymyalgia Rheumatica
- Being tested
- Nivolumab
- Keywords
- Autoimmune Diseases, Non-small Cell Lung Cancer, Ulcerative Colitis, Multiple Sclerosis, Crohn Disease, Systemic Lupus Erythematosus, Polymyalgia Rheumatica, Giant Cell Arteritis, Psoriasis, Rheumatoid Arthritis, Nivolumab, Opdivo
- Medical subject headings
- Autoimmune Diseases, Carcinoma, Non-Small-Cell Lung, Arthritis, Rheumatoid, Psoriasis, Giant Cell Arteritis, Polymyalgia Rheumatica, Lupus Erythematosus, Systemic, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Nivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle.
For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab: Autoimmune Diseases Cohort 1 | Experimental | Arms determined by autoimmune type. First cohort consists of patients with:
Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis
If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2. Receives: Drug: Nivolumab |
| Nivolumab: Autoimmune Diseases Cohort 2 | Experimental | Arms determined by autoimmune type. Second cohort consists of patients with:
Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment.
If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
The DLT determination period is the first six weeks after cycle 1 day 1. Dose limiting toxicities are further defined in the trial protocol.
Measured: 48 Months
Secondary outcomes (3)
Overall Response Rate
Overall response rate is defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence
Measured: 48 Months
Progression-Free Survival
Progression-free survival will be evaluated for each cohort using Kaplan-Meier estimator.
Measured: 48 Months
Overall Survival
Overall survival will be evaluated for each cohort using Kaplan-Meier estimator.
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start27 Jun 2019
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656627
- Sponsor's protocol ID
- AFT-42
- Status last verified
- Feb 2023
- First submitted
- 31 Aug 2018
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.
PubMed 22473918Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
PubMed 7818570van der Heijde DM, van Leeuwen MA, van Riel PL, Koster AM, van 't Hof MA, van Rijswijk MH, van de Putte LB. Biannual radiographic assessments of hands and feet in a three-year prospective followup of patients with early rheumatoid arthritis. Arthritis Rheum. 1992 Jan;35(1):26-34. doi: 10.1002/art.1780350105.
PubMed 1731813Wijnands MJ, van't Hof MA, van Leeuwen MA, van Rijswijk MH, van de Putte LB, van Riel PL. Long-term second-line treatment: a prospective drug survival study. Br J Rheumatol. 1992 Apr;31(4):253-8. doi: 10.1093/rheumatology/31.4.253.
PubMed 1348198Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S93-9.
PubMed 16273792Leeb BF, Bird HA. A disease activity score for polymyalgia rheumatica. Ann Rheum Dis. 2004 Oct;63(10):1279-83. doi: 10.1136/ard.2003.011379.
PubMed 15361387Leeb BF, Bird HA, Nesher G, Andel I, Hueber W, Logar D, Montecucco CM, Rovensky J, Sautner J, Sonnenblick M. EULAR response criteria for polymyalgia rheumatica: results of an initiative of the European Collaborating Polymyalgia Rheumatica Group (subcommittee of ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1189-94. doi: 10.1136/ard.2002.002618.
PubMed 14644857Leeb BF, Rintelen B, Sautner J, Fassl C, Bird HA. The polymyalgia rheumatica activity score in daily use: proposal for a definition of remission. Arthritis Rheum. 2007 Jun 15;57(5):810-5. doi: 10.1002/art.22771.
PubMed 17530664Seror R, Theander E, Brun JG, Ramos-Casals M, Valim V, Dorner T, Bootsma H, Tzioufas A, Solans-Laque R, Mandl T, Gottenberg JE, Hachulla E, Sivils KL, Ng WF, Fauchais AL, Bombardieri S, Valesini G, Bartoloni E, Saraux A, Tomsic M, Sumida T, Nishiyama S, Caporali R, Kruize AA, Vollenweider C, Ravaud P, Vitali C, Mariette X, Bowman SJ; EULAR Sjogren's Task Force. Validation of EULAR primary Sjogren's syndrome disease activity (ESSDAI) and patient indexes (ESSPRI). Ann Rheum Dis. 2015 May;74(5):859-66. doi: 10.1136/annrheumdis-2013-204615. Epub 2014 Jan 17.
PubMed 24442883Puzenat E, Bronsard V, Prey S, Gourraud PA, Aractingi S, Bagot M, Cribier B, Joly P, Jullien D, Le Maitre M, Paul C, Richard-Lallemand MA, Ortonne JP, Aubin F. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010 Apr;24 Suppl 2:10-6. doi: 10.1111/j.1468-3083.2009.03562.x.
PubMed 20443995Chow C, Simpson MJ, Luger TA, Chubb H, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment. J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1406-14. doi: 10.1111/jdv.13132. Epub 2015 Apr 27.
PubMed 25917315Cooney RM, Warren BF, Altman DG, Abreu MT, Travis SP. Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation. Trials. 2007 Jun 25;8:17. doi: 10.1186/1745-6215-8-17.
PubMed 17592647Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut. 1998 Jul;43(1):29-32. doi: 10.1136/gut.43.1.29.
PubMed 9771402Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005 Jun;54(6):782-8. doi: 10.1136/gut.2004.056358.
PubMed 15888785Jowett SL, Seal CJ, Phillips E, Gregory W, Barton JR, Welfare MR. Defining relapse of ulcerative colitis using a symptom-based activity index. Scand J Gastroenterol. 2003 Feb;38(2):164-71. doi: 10.1080/00365520310000654.
PubMed 12678333
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
- ClinicalTrials.gov ID
- NCT03656627
- Acronym / sponsor ID
- AFT-42
- Conditions
- Autoimmune Diseases, Non-small Cell Lung Cancer, Rheumatoid Arthritis, Psoriasis, Giant Cell Arteritis, Polymyalgia Rheumatica
- Keywords
- Autoimmune Diseases, Non-small Cell Lung Cancer, Ulcerative Colitis, Multiple Sclerosis, Crohn Disease, Systemic Lupus Erythematosus, Polymyalgia Rheumatica, Giant Cell Arteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alliance Foundation Trials, LLC.University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type.
Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.
Detailed description
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type as outlined below. Entry into cohorts 1 and 2 will start simultaneously and enroll independently.
Cohort 1: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis Cohort 2: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment.
Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level.
Participants will be followed with telephone follow up for two years after removal from protocol therapy or until death, whichever occurs first. Phone calls will be placed every six months and survival follow up obtained. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event, in addition to the follow up for two years after removal from protocol therapy or until death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab: Autoimmune Diseases Cohort 1 | Experimental | Drug: NivolumabArms determined by autoimmune type. First cohort consists of patients with: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2. |
| Nivolumab: Autoimmune Diseases Cohort 2 | Experimental | Drug: NivolumabArms determined by autoimmune type. Second cohort consists of patients with: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment. If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age > 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Metastatic, locally advanced or recurrent NSCLC, not amenable to curative therapy.
- Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy.
- Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy
Key exclusion criteria (11 listed)
- No chemotherapy or radiotherapy within two weeks of study entry. Prior targeted therapy is allowed as long as at least 5 half-lives have elapsed since last dose.
- All adverse events (other than alopecia) from prior therapy must be resolved to Grade 1 or less.
- Patients who are known to be HIV positive are excluded due to the known immunologic alterations associated with the disease. HIV testing is not required.
- No uncontrolled intercurrent illness such as active infection, or psychiatric illness or social situation that in the judgment of the investigator would limit compliance with study requirements
- No active interstitial lung disease (ILD) or pneumonitis, or a history of ILD or pneumonitis requiring treatment with corticosteroids
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 |
|---|---|---|
| NivolumabNivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level. | Drug | Nivolumab: Autoimmune Diseases Cohort 1, Nivolumab: Autoimmune Diseases Cohort 2 |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: 48 Months
The DLT determination period is the first six weeks after cycle 1 day 1. Dose limiting toxicities are further defined in the trial protocol.
3 secondary outcomes
Overall Response Rate
Time frame: 48 Months
Progression-Free Survival
Time frame: 48 Months
Overall Survival
Time frame: 48 Months
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 22473918Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.
- Background: PubMed 7818570Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
- Background: PubMed 1731813van der Heijde DM, van Leeuwen MA, van Riel PL, Koster AM, van 't Hof MA, van Rijswijk MH, van de Putte LB. Biannual radiographic assessments of hands and feet in a three-year prospective followup of patients with early rheumatoid arthritis. Arthritis Rheum. 1992 Jan;35(1):26-34. doi: 10.1002/art.1780350105.
- Background: PubMed 1348198Wijnands MJ, van't Hof MA, van Leeuwen MA, van Rijswijk MH, van de Putte LB, van Riel PL. Long-term second-line treatment: a prospective drug survival study. Br J Rheumatol. 1992 Apr;31(4):253-8. doi: 10.1093/rheumatology/31.4.253.
- Background: PubMed 16273792Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S93-9.
- Background: PubMed 15361387Leeb BF, Bird HA. A disease activity score for polymyalgia rheumatica. Ann Rheum Dis. 2004 Oct;63(10):1279-83. doi: 10.1136/ard.2003.011379.
- Background: PubMed 14644857Leeb BF, Bird HA, Nesher G, Andel I, Hueber W, Logar D, Montecucco CM, Rovensky J, Sautner J, Sonnenblick M. EULAR response criteria for polymyalgia rheumatica: results of an initiative of the European Collaborating Polymyalgia Rheumatica Group (subcommittee of ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1189-94. doi: 10.1136/ard.2002.002618.
- Background: PubMed 17530664Leeb BF, Rintelen B, Sautner J, Fassl C, Bird HA. The polymyalgia rheumatica activity score in daily use: proposal for a definition of remission. Arthritis Rheum. 2007 Jun 15;57(5):810-5. doi: 10.1002/art.22771.
- Background: PubMed 24442883Seror R, Theander E, Brun JG, Ramos-Casals M, Valim V, Dorner T, Bootsma H, Tzioufas A, Solans-Laque R, Mandl T, Gottenberg JE, Hachulla E, Sivils KL, Ng WF, Fauchais AL, Bombardieri S, Valesini G, Bartoloni E, Saraux A, Tomsic M, Sumida T, Nishiyama S, Caporali R, Kruize AA, Vollenweider C, Ravaud P, Vitali C, Mariette X, Bowman SJ; EULAR Sjogren's Task Force. Validation of EULAR primary Sjogren's syndrome disease activity (ESSDAI) and patient indexes (ESSPRI). Ann Rheum Dis. 2015 May;74(5):859-66. doi: 10.1136/annrheumdis-2013-204615. Epub 2014 Jan 17.
- Background: PubMed 20443995Puzenat E, Bronsard V, Prey S, Gourraud PA, Aractingi S, Bagot M, Cribier B, Joly P, Jullien D, Le Maitre M, Paul C, Richard-Lallemand MA, Ortonne JP, Aubin F. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010 Apr;24 Suppl 2:10-6. doi: 10.1111/j.1468-3083.2009.03562.x.
- Background: PubMed 25917315Chow C, Simpson MJ, Luger TA, Chubb H, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment. J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1406-14. doi: 10.1111/jdv.13132. Epub 2015 Apr 27.
- Background: PubMed 17592647Cooney RM, Warren BF, Altman DG, Abreu MT, Travis SP. Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation. Trials. 2007 Jun 25;8:17. doi: 10.1186/1745-6215-8-17.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab in people with Autoimmune Diseases and Non-small Cell Lung Cancer, run by Alliance Foundation Trials, LLC. at 9 sites 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 27 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Dose-Limiting Toxicity (DLT) (time frame: 48 Months). 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 NCT03656627, which also lists 21 linked publications.
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 15 Feb 2023.